MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-13 for VITROS CHEMISTRY PRODUCTS AMPH REAGENT 6801991 manufactured by Ortho-clinical Diagnostics.
[19870205]
A false negative vitros amph result was obtained from a single proficiency sample while using the vitros 5,1 fs chemistry system. The magnitude and direction of the false negative vitros amph result observed may lead to inappropriate physician action if it occurred undetected on a patient sample. Patient samples were not affected and there was no allegation of patient harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20279593]
Investigation into this event concluded that a false negative vitros amph result occurred, and was isolated to a specific test event of a single proficiency sample. Investigation was unable to determine an assignable cause. No instrument or reagent malfunction was identified as a contributing factor. A pre-analytical user error involving sample mix up cannot be confirmed or ruled out as a contributing factor. Root cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2011-00029 |
| MDR Report Key | 2293402 |
| Report Source | 05 |
| Date Received | 2011-10-13 |
| Date of Report | 2011-10-13 |
| Date of Event | 2011-06-17 |
| Date Mfgr Received | 2011-09-16 |
| Device Manufacturer Date | 2011-01-14 |
| Date Added to Maude | 2012-07-06 |
| 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 | 2011-10-13 |
| Catalog Number | 6801991 |
| Lot Number | 1521-02-1139 |
| Device Expiration Date | 2011-09-01 |
| 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 | 2011-10-13 |