MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-08 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.
[3287227]
A customer observed multiple, reproducible, lower than expected vitros gent quality control results (qc fluid biorad 2= 5. 21, 5. 66 vs. An expected result= 8. 60 ng/ml) on a vitros 5,1 fs chemistry system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. No patient samples were run during the time frame of the event. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10581045]
The investigation determined that multiple, reproducible, lower than expected vitros gent quality control results were obtained on a vitros 5,1 fs chemistry system. The investigation was unable to determine a definitive root cause; however, the most likely cause is associated with the reagent. There was no evidence that an instrument related issue contributed to the event. Expected performance was obtained using an alternate vitros gent reagent lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2013-00010 |
| MDR Report Key | 2950696 |
| Report Source | 05 |
| Date Received | 2013-02-08 |
| Date of Report | 2013-02-08 |
| Date of Event | 2013-01-10 |
| Date Mfgr Received | 2013-01-10 |
| Device Manufacturer Date | 2012-02-16 |
| Date Added to Maude | 2013-04-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JOSEPH FALVO |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 1000 LEE ROAD |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS GENT REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LCD |
| Date Received | 2013-02-08 |
| Catalog Number | 6801711 |
| Lot Number | 1512-08-2025 |
| Device Expiration Date | 2013-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-08 |