MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-13 for VITROS CHEMISTRY PRODUCTS OP REAGENT 6801997 manufactured by Ortho-clinical Diagnostics.
[62677558]
The investigation determined that a discordant, negative vitros op-lo result was obtained from a single patient sample run on the vitros 5600 integrated system. The intended use section of the vitros op ifu states that the vitros chemistry product op assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with the vitros op assay. Gas chromatography/mass spectrometry (gcms) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result. The likely cause is a known limitation of the vitros op reagent related to low cross reactivity with oxymorphone and oxycodone. Although there is no indication that the instrument was not performing as intended, an instrument issue cannot be completely ruled out as a contributing factor to the event. There is no information to suggest that the vitros op reagent malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[62677559]
The customer obtained a discordant, negative vitros op-lo result from a single patient sample run on the vitros 5600 integrated system, when compared to a positive opiate result obtained using the gc/ms method. Vitros patient result: 279 ng/ml (positive cutoff >or = 300 ng/ml) vs. >positive (2500 ng/ml oxycodone and 620 ng/ml oxymorphone). Biased results of the magnitude and direction observed may lead to inappropriate physician action. The discordant vitros op-lo result was reported out of the laboratory. However, there was no report of treatment started, stopped, or altered based on the false negative vitros op-lo result and there was no report of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2016-00042 |
| MDR Report Key | 6169007 |
| Date Received | 2016-12-13 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-11-17 |
| Date Mfgr Received | 2016-11-28 |
| Device Manufacturer Date | 2016-03-10 |
| Date Added to Maude | 2016-12-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| 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 | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS OP REAGENT |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | DJG |
| Date Received | 2016-12-13 |
| Catalog Number | 6801997 |
| Lot Number | 1527-09-5274 |
| Device Expiration Date | 2017-09-10 |
| 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 | 2016-12-13 |