MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-14 for VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HIV 1 + 2 REAGENT PACK 6801861 manufactured by Ortho-clinical Diagnostics.
[19176529]
A customer observed false negative (b) (6) results for two samples obtained from one patient and tested on a vitros eci analyzer. The results did not agree with alternate testing done with an alternate (b) (6) assay and western blot testing on the same samples. The laboratory did not report the false negative vitros (b) (6) result and there was no allegation of harm.
Patient Sequence No: 1, Text Type: D, B5
[19344720]
Investigation into this event showed that the issue was related to one patient and two specimens from that patient. The samples were tested as part of a comparison test. The alternate assay testing had been performed 3 (sample 2) and 7 (sample 1) months prior to the vitros (b) (6) assay testing. Samples were stored refrigerated for more than 2 days and then frozen prior to testing on the vitros assay. The sample storage exceeded the storage recommendations in the vitros (b) (6) assay instructions for use. Analysis of instrument datalogger files found no evidence to suggest the results in question were caused by an analyzer or reagent malfunction. The investigation was unable to conclude a definite root cause of this event. There was no allegation of patient harm as result of this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680658-2008-00241 |
| MDR Report Key | 1120006 |
| Report Source | 05 |
| Date Received | 2008-08-14 |
| Date of Report | 2008-07-16 |
| Date of Event | 2008-07-16 |
| Date Mfgr Received | 2008-07-16 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2009-11-18 |
| 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 Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854535735 |
| 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 DIAGNOSTICS |
| Product Code | MTL |
| Date Received | 2008-08-14 |
| Model Number | NA |
| Catalog Number | 6801861 |
| Lot Number | 0030 |
| ID Number | NA |
| Device Expiration Date | 2008-11-05 |
| 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 14626510 US 14626 5101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-14 |