MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-03 for VITROS IMMUNODIAGNOSTICS PRODUCTS AHAV IGM REAGENT PACK 680 1812 manufactured by Ortho-clinical Diagnostics.
[828040]
A customer observed falsely reactive ahav igm results from a single pt tested on the vitros eci analyzer. The results did not agree with results generated on a competitive method. Quality control results were within acceptable ranges. Erroneous anti-hav igm results may lead to confusion in the diagnosis and treatment of acute hepatitis. The reactive vitros result was reported, however, there was no allegation of harm as a result of this event. Note: there are two consecutively numbered form 3500a being filed for this event. The falsely reactive ahav igm results were obtained on two different ahav igm reagent lots (lot 1110, mdr #9680658-2008-00091 and lot 1160, mdr #9680658-2008-00092).
Patient Sequence No: 1, Text Type: D, B5
[8006876]
Investigation into this event found that the reactive results occurred with two different vitros ahav igm reagent lots and on two different vitros eci systems. The root cause of the reactive results could not be determined, however, the pt's condition and other test results indicate that the true classification of the sample is ahav igm negative. While the cause is unk, it is not due to the analyzer, which performed acceptably, but might be due to a sample interferent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680658-2008-00091 |
| MDR Report Key | 1026515 |
| Report Source | 05 |
| Date Received | 2008-04-03 |
| Date of Report | 2008-03-06 |
| Date of Event | 2008-02-29 |
| Date Mfgr Received | 2008-03-06 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2009-02-20 |
| 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 CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854535735 |
| Manufacturer Street | FOREST FARM ESTATE WHITCHURCH |
| Manufacturer City | 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 AHAV IGM REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | CFQ |
| Date Received | 2008-04-03 |
| Model Number | NA |
| Catalog Number | 680 1812 |
| Lot Number | 1110 |
| ID Number | NA |
| Device Expiration Date | 2008-04-08 |
| 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 | 2008-04-03 |