MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-06 for VITROS CHEMISTRY PRODUCTS BENZ REAGENT 6801989 manufactured by Ortho-clinical Diagnostics.
[20988137]
The customer obtained unexpected negative vitros benz results (< 200 ng/ml cutoff value) from two patient samples run on the vitros 5600 integrated system. The negative vitros benz results were considered to be unexpected based on positive benz results obtained using an alternate urine drug screening device and at a reference laboratory (benz compounds detected > 800 ng/ml). Biased results of the magnitude and direction observed may lead to inappropriate physician action. The unexpected negative vitros benz results were initially reported out of the laboratory. However, there was no report of patient harm as a result of this event. This report is number two of two mdr? S for this event. Two 3500a forms are being submitted for this event as two devices were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21143292]
The investigation determined that unexpected negative vitros benz results were obtained from two patient samples run on the vitros 5600 integrated system. Two different vitros benz reagent lots were affected by this issue. There was no evidence to suggest that an instrument malfunction occurred. The intended use section of the vitros benz ifu states that the vitros chemistry products benz 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 investigation was unable to determine a definitive root cause. A vitros benz reagent issue or sample mix-up cannot be ruled out as potential contributing factors. However, there is no specific evidence to suggest that sample mix-up occurred beyond the unexpected results themselves. The root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2013-00047 |
| MDR Report Key | 3453498 |
| Report Source | 05 |
| Date Received | 2013-11-06 |
| Date of Report | 2013-11-06 |
| Date of Event | 2013-09-18 |
| Date Mfgr Received | 2013-10-08 |
| Device Manufacturer Date | 2013-08-21 |
| Date Added to Maude | 2014-02-05 |
| 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 BENZ REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JXM |
| Date Received | 2013-11-06 |
| Catalog Number | 6801989 |
| Lot Number | 1523-15-3153 |
| Device Expiration Date | 2014-08-01 |
| 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 | 2013-11-06 |