STATSTRIP GLUCOSE HOSPITAL METER SYSTEM Adverse Event — Malfunction (MDR 1219029-2020-00033)
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM Adverse Event — Malfunction (MDR 1219029-2020-00033) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; Generic name: BLOOD GLUCOSE METER; Manufacturer: NOVA BIOMEDICAL CORP.
| Device | STATSTRIP GLUCOSE HOSPITAL METER SYSTEM |
|---|---|
| Generic name | BLOOD GLUCOSE METER |
| Manufacturer | NOVA BIOMEDICAL CORP |
| Report number | 1219029-2020-00033 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, U |
| Narrative | ADDITIONAL INFORMATION: H4, H10. CORRECTED INFORMATION: D5, G4, G7, H1, H2. THE DEVICE HISTORY RECORD (DHR) REVIEW INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING AND RELEASE OF THE METER. NO ABNORMALITIES OR CONCERNS WERE OBSERVED; THE DHR INDICATED THAT THE RELEASE PRODUCT MET ALL SPECIFICATIONS. THERE IS CURRENTLY A PENDING INVESTIGATION AND FURTHER DETAILS WILL BE PROVIDED IN AN ADDITIONAL S |
| Source | openFDA MAUDE (device adverse events) |
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