MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-17 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.
[2844073]
A customer observed lower than expected vitros gent proficiency results on a vitros 5600 integrated system. A value of 5. 7 g/ml was obtained from proficiency sample t67 versus the expected value of 8. 3 g/ml. A value of 9. 2 g/ml was obtained from proficiency sample t68 versus the expected value of 14. 0 g/ml. A value of 9. 7 g/ml was obtained from proficiency sample t70 versus the expected value of 15. 3 g/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10070743]
The investigation determined that lower than expected vitros gent proficiency results were obtained on a vitros 5600 integrated system. The investigation found no evidence to suggest that an instrument malfunction contributed to the event. Acceptable results were obtained using the same vitros gent reagent lot when the proficiency samples were repeated at a later date. The investigation was unable to determine a definitive root cause. However, an issue with the vitros gent reagent, the fs diluent pack 2, or improper sample handling could not be ruled out as potential contributing factors. Ocd has received no related customer complaints for vitros gent lot 1512-07-1283 to suggest a product issue. The root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2012-00022 |
| MDR Report Key | 2658372 |
| Report Source | 05 |
| Date Received | 2012-07-17 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-05-09 |
| Date Mfgr Received | 2012-06-18 |
| Device Manufacturer Date | 2011-02-18 |
| Date Added to Maude | 2012-11-05 |
| 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 | 2012-07-17 |
| Catalog Number | 6801711 |
| Lot Number | 1512-07-1283 |
| Device Expiration Date | 2012-11-30 |
| 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 | 2012-07-17 |