MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-08 for VITROS CHEMISTRY PRODUCTS OP REAGENT 6801997 manufactured by Ortho-clinical Diagnostics.
[3486548]
A customer obtained a non-reproducible, discordant negative vitros op-lo result (294(negative) vs. An expected result > 300 ng/ml (positive)) for a positive cap proficiency sample run on the vitros 5, 1 fs chemistry system. Biased results of the magnitude and direction observed may lead to inappropriate physician action. There was no report that patient sample 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
[10773848]
The investigation confirmed that a customer obtained a non-reproducible, discordant negative vitros op-lo result (294 ng/ml (negative) vs. An expected result > 300 ng/ml (positive)) for a positive cap proficiency sample run on the vitros 5, 1 fs chemistry. The investigation determined that the sample contained oxycodone at a target concentration of 2000 ng/ml. As per the vitros op instructions for use (ifu), at the 300 ng/ml cutoff, vitros op reagent has a 15% cross reactivity with oxycodone. In addition, the investigation determined that the op-lo calibration in use at the time of the event was negatively biased. The most likely cause of the event was a combination of a known limitation of the vitros op reagent related to low cross reactivity with oxycodone and the op-lo calibration in use at the time of the event. There was no evidence that an instrument related issue contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2013-00034 |
| MDR Report Key | 3156885 |
| Report Source | 05 |
| Date Received | 2013-06-08 |
| Date of Report | 2013-06-07 |
| Date of Event | 2013-03-15 |
| Date Mfgr Received | 2013-05-09 |
| Device Manufacturer Date | 2012-08-22 |
| Date Added to Maude | 2013-09-03 |
| 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 | 2013-06-08 |
| Catalog Number | 6801997 |
| Lot Number | 1527-07-2374 |
| Device Expiration Date | 2013-11-01 |
| 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 | 2013-06-08 |