MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-10 for VITROS CHEMISTRY PRODUCTS OP REAGENT 6801997 manufactured by Ortho-clinical Diagnostics.
[3773471]
A customer obtained a discordant, negative vitros op-lo result (182. 9 ng/ml) vs. An expected opiate result of 3078 ng/ml for single patient sample run on the vitros 5600 integrated system. The discordant, negative result was reported out of the laboratory. Biased patient results of the direction and magnitude observed could lead to inappropriate physician action. The physician questioned the discordant, negative result as a positive test result was expected based the patient? S clinical presentation. The sample was sent for confirmatory testing using a gc/ms method, which detected the presence of opiates. A corrected report was not issued. The customer was unable to confirm whether any patient treatment was started, stopped, or altered based on the initial discordant negative vitros op-lo result reported, however, there was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11210004]
The investigation determined that a discordant, negative vitros op-lo result was obtained from a single patient sample using 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 (gc/ms) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result. The most likely cause is a known limitation of the vitros op reagent related to low cross reactivity with oxymorphone. There is no evidence that a reagent related issue contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2013-00044 |
| MDR Report Key | 3404640 |
| Report Source | 05 |
| Date Received | 2013-10-10 |
| Date of Report | 2013-10-10 |
| Date of Event | 2013-09-04 |
| Date Mfgr Received | 2013-09-13 |
| Device Manufacturer Date | 2012-11-06 |
| Date Added to Maude | 2014-01-14 |
| 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 | 2013-10-10 |
| Catalog Number | 6801997 |
| Lot Number | 1527-07-2586 |
| Device Expiration Date | 2014-03-01 |
| 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 | 2013-10-10 |