MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-19 for VITROS CHEMISTRY PRODUCTS OP REAGENT 6801997 manufactured by Ortho-clinical Diagnostics.
[3086853]
A customer obtained unexpected repeatable discordant vitros op results (230, 232 ng/ml vs. An expected result > 300 ng/ml) for single patient sample run on the vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action. The results were reported from the laboratory. However, the physician questioned the result and the sample was sent for confirmatory testing that detected the presence of opiates. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10233231]
The investigation confirmed that a customer obtained unexpected repeatable discordant vitros op results while using the vitros 5600 integrated system. There was no evidence to suggest an instrument or reagent malfunction had occurred. The investigation was unable to determine a definitive root cause. The possibility that a negative bias exists with vitros op assay when compared to the alternate (gc/ms) method cannot be ruled out. The root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2012-00036 |
| MDR Report Key | 2797819 |
| Report Source | 05 |
| Date Received | 2012-10-19 |
| Date of Report | 2012-10-19 |
| Date of Event | 2012-09-19 |
| Date Mfgr Received | 2012-09-21 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2013-01-31 |
| 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 OP REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DJG |
| Date Received | 2012-10-19 |
| Catalog Number | 6801997 |
| Lot Number | 1527-07-1977 |
| Device Expiration Date | 2013-06-01 |
| 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 | 2012-10-19 |