MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-12 for VITROS CHEMISTRY PRODUCTS AMPH REAGENT 6801991 manufactured by Ortho-clinical Diagnostics.
[3935997]
The customer obtained an unexpected negative vitros amph result (999. 2 ng/ml, negative using vitros amph cutoff of 1,000 ng/ml) from a single proficiency sample run on the vitros 5600 integrated system. The negative vitros amph result was considered to be unexpected based on the target d-amphetamine concentration of 2,000 ng/ml for the proficiency sample in question. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. There was no report 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
[11279850]
The investigation determined that an unexpected negative vitros amph result was obtained from a single proficiency sample run on the vitros 5600 integrated system. Repeat testing on a later date using the same vitros amph reagent lot generated expected positive results. However, all results obtained were close to the cutoff value of 1,000 ng/ml and the difference observed between the initial and repeat tests is consistent with expected variability of the vitros amph assay. Vitros amph quality control results were acceptable near the date of the event, however overall accuracy of the vitros amph lot in use could not be confirmed based on the limited data available. An alternate vitros amph reagent lot was put into use, and positive amph results were obtained as expected. A definitive root cause of the unexpected negative vitros amph result was not determined. An issue with sample handling or a reagent issue cannot be ruled out as potential contributing factors. The root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2013-00051 |
| MDR Report Key | 3463840 |
| Report Source | 05 |
| Date Received | 2013-11-12 |
| Date of Report | 2013-11-12 |
| Date of Event | 2013-06-19 |
| Date Mfgr Received | 2013-10-14 |
| Device Manufacturer Date | 2013-04-02 |
| Date Added to Maude | 2014-02-18 |
| 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 AMPH REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DKZ |
| Date Received | 2013-11-12 |
| Catalog Number | 6801991 |
| Lot Number | 1521-04-2879 |
| Device Expiration Date | 2014-02-01 |
| 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 | 2013-11-12 |