MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-12 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.
[2773613]
A customer observed lower than expected vitros gent quality control results on a vitros 5600 integrated system. Values of 5. 44, 3. 83, 4. 70, and 4. 41 ug/ml were obtained from the biorad level 2 fluid versus the expected value or 7. 83 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. No patient samples were run for vitros gent during the time frame of this event. There was no report of patient harm as a result of this event. This report is number two of three mdr's for this event. Three 3500a forms are being submitted for this event as three devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9997733]
The investigation determined that lower than expected vitros gent quality control results were obtained on a vitros 5600 integrated system. The customer depleted their inventory of vitros gent lot 1512-07-1075, therefore, no additional performance tests were completed using the affected reagent lot. Ocd has received no related customer complaints for vitros gent lot 1512-07-1075 to suggest a reagent issue. An alternate lot of vitros gent reagent generated acceptable quality control performance. The investigation was unable to determine a definitive root cause. However, the vitros gent reagent could not be ruled out as a potential contributing factor. The investigation found no evidence to suggest that an issue with the vitros 5600 integrated system contributed to this event. The root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2012-00020 |
| MDR Report Key | 2653829 |
| Report Source | 05 |
| Date Received | 2012-07-12 |
| Date of Report | 2012-07-12 |
| Date of Event | 2012-05-31 |
| Date Mfgr Received | 2012-06-13 |
| Device Manufacturer Date | 2010-10-25 |
| Date Added to Maude | 2012-10-26 |
| 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 | 2012-07-12 |
| Catalog Number | 6801711 |
| Lot Number | 1512-07-1075 |
| Device Expiration Date | 2012-08-31 |
| 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 | 2012-07-12 |