MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-22 for VITROS CHEMISTRY PRODUCTS AMPH REAGENT 6801991 manufactured by Ortho-clinical Diagnostics.
[1255390]
The customer obtained false negative results for a single proficiency fluid sample processed using vitros amph reagent on a vitros 5,1 fs system. The expected result for the sample was positive. Biased results of the direction and magnitude observed could lead to inappropriate physician action. Pt samples would be affected if the same circumstance occurred. There was no report of pt harm as a result of this event. This report corresponds to ortho clinical diagnostics inc.
Patient Sequence No: 1, Text Type: D, B5
[8321580]
The proficiency report for the sample indicated that the sample contained methylenedioxy - methamphetamine (mdma). The mdma concentration in the sample was greater than the lab cutoff of 1000 ng/ml, and was therefore considered to be positive for amphetamines. The analytical specificity section of the vitros amph ifu states that the vitros amph has a low cross-reactivity with mdma. The low cross-reactivity is the cause of the false negative proficiency fluid results for the sample. The intended use section of the vitros amph ifu, also states that the vitros chemistry products amph assay provide only a preliminary test result. A more specific alternative chemical method must be used to confirm results 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, particularly when evaluating a preliminary positive result. The root cause of this event is a known limitation of the vitros amph assay and user error in the interpretation of a positive vitros amph result.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2009-00412 |
| MDR Report Key | 1565004 |
| Report Source | 05 |
| Date Received | 2009-12-22 |
| Date of Report | 2009-12-03 |
| Date of Event | 2009-10-07 |
| Date Mfgr Received | 2009-12-03 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2009-12-30 |
| 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 | JOSEPH FALVO |
| Manufacturer Street | 100 INDIGO CREEK DR |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854535735 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 1000 LEE RD. |
| 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 AMPH REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DKZ |
| Date Received | 2009-12-22 |
| Model Number | NA |
| Catalog Number | 6801991 |
| Lot Number | 1521-01-8978 |
| ID Number | NA |
| Device Expiration Date | 2010-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DR ROCHESTER NY 14626510 US 14626 5101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-22 |