MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-27 for VITROS CHEMISTRY PRODUCTS OP REAGENT 6801997 manufactured by Ortho-clinical Diagnostics.
[78986228]
The investigation determined that unexpected discordant vitros op negative results were obtained from samples from three separate patients which were reported as op negative when the physician expected a positive op result from all three patients when tested on a vitros 5600 integrated chemistry system. The vitros chemistry products 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 this 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 likely cause is a known limitation of the vitros op reagent related to low cross reactivity with synthetic opioids. The customer did not send the samples for additional testing to confirm. There is no evidence to suggest that the vitros op reagent lot 1527-09-5708 malfunctioned. 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
[78986229]
A customer obtained unexpected discordant vitros op negative results using a <300 ng/ml cutoff from samples from three separate patients which were reported as op negative when the physician expected a positive op result from all three patients due to their condition (heroin overdose), on a vitros 5600 integrated chemistry system. Patient 1 vitros result < 100 ng/ml (negative) versus an expected positive result (>300 ng/ml). Patient 2 vitros result < 100 ng/ml (negative) versus an expected positive result (>300 ng/ml). Patient 3 vitros result < 100 ng/ml (negative) versus an expected positive result (>300 ng/ml). Biased results of the magnitude and direction observed may lead to inappropriate physician action. The discordant vitros op-lo results were reported out of the laboratory. However, there was no report of treatment started, stopped, or altered based on the false negative vitros op-lo results and there was no report of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics (ortho) inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00010 |
| MDR Report Key | 6669466 |
| Date Received | 2017-06-27 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-05-31 |
| Date Mfgr Received | 2017-05-31 |
| Date Added to Maude | 2017-06-27 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 2017-06-27 |
| Catalog Number | 6801997 |
| Lot Number | 1527-09-5708 |
| ID Number | 10758750001835 |
| Device Expiration Date | 2018-03-31 |
| 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 | 2017-06-27 |