MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-22 for VITROS CHEMISTY PRODUCTS AMPH REAGENT 6801991 manufactured by .
[34937037]
The investigation determined that a lower than expected vitros amph proficiency result occurred on a vitros 5,1 fs system. The investigation concludes that a false negative vitros amph result was obtained from a proficiency sample based on a measured mdma value of 1500 ng/ml. The root cause is a known limitation of the vitros amph reagent. The mdma compound has a low cross reactivity with the vitros amph reagent as stated in the vitros amph instructions for use (ifu). The vitros 5600 system did not malfunction.
Patient Sequence No: 1, Text Type: N, H10
[34937038]
A customer observed a lower than expected vitros amph result from a proficiency sample fluid processed on a vitros 5600 integrated system. Vitros amph proficiency results: sample result: 998 ng/ml (negative) versus expected result 1500 ng/ml (positive) using a cutoff of 1000 ng/ml. The customer made no allegations that patient sample results were affected. However, biased patient results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected. There was no allegation 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 | 1319808-2015-00022 |
| MDR Report Key | 5318941 |
| Date Received | 2015-12-22 |
| Date of Report | 2015-12-22 |
| Date of Event | 2015-10-13 |
| Date Mfgr Received | 2015-11-24 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2015-12-22 |
| 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 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 CHEMISTY PRODUCTS AMPH REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DKZ |
| Date Received | 2015-12-22 |
| Catalog Number | 6801991 |
| Lot Number | 1521-04-4599 |
| Device Expiration Date | 2016-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-22 |