MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-11 for VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HIV 1 + 2 REAGENT PACK 6801861 manufactured by Ortho-clinical Diagnostics.
[19681149]
A customer observed repeatable, false positive anti-hive (vitros ahiv 1 + 2 assay) results for multiple samples obtained from one patient tested on a vitros eci analyzer. The results did not agree with results from an alternate ahiv assay and western blot testing on the same samples. The false positive result was reported, and the patient was treated. There were no allegations of harm as a result of the treatment given.
Patient Sequence No: 1, Text Type: D, B5
[19743529]
Investigation into this event showed that the false positive results were related to multiple samples from a single patient. Analysis of instrument datalogger files found no evidence to suggest the results in question were caused by an analyzer, or reagent malfunction. Testing with heterophile antibody blocking tubes ruled out heterophilic antibody interference. The investigation was unable to determine a definitive root cause, however, an unknown interferent (other than heterophilic antibodies) cannot be ruled out.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680658-2008-00270 |
| MDR Report Key | 1161467 |
| Report Source | 05 |
| Date Received | 2008-09-11 |
| Date of Report | 2008-08-13 |
| Date of Event | 2008-08-12 |
| Date Mfgr Received | 2008-08-13 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2009-04-10 |
| 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 | JOE FALVO |
| Manufacturer Street | 100 INDIGO CREED DRIVE |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854535743 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | FOREST FARM ESTATE |
| Manufacturer City | WHITCHURCH, CARDIFF CF147YT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF14 7YT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HIV 1 + 2 REAGENT PACK |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | MTL |
| Date Received | 2008-09-11 |
| Model Number | NA |
| Catalog Number | 6801861 |
| Lot Number | 0040 |
| ID Number | NA |
| Device Expiration Date | 2009-01-24 |
| 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 DRIVE ROCHESTER NY 14625510 US 14625 5101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-11 |