MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-07-02 for VITROS CHEMISTRY PRODUCTS BARB REAGENT PACK 680 1988 manufactured by Ortho-clinical Diagnostics.
[22047248]
Investigation into this event found that the vitros 5, 1 and vitros barb reagent were operating as intended. The investigation determined that the proficiency sample produced a vitros barb result of 258 ng/ml which was very close to the theoretical concentration. However, it was less than the qualitative cutoff of 300 ng/ml in use by the customer and was reported as negative. Any result other than positive was graded as a failure.
Patient Sequence No: 1, Text Type: N, H10
[22072903]
The customer obtained a false negative proficiency result using vitros barb reagent on the vitros 5, 1 fs chemistry system. The weighed in amount of amobarbitol was expected to produce a positive result. Biased results of the direction and magnitude observed may lead to inappropriate physician action. There was no report of pt harm as the sample involved was a proficiency sample, and not a pt sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2008-00203 |
| MDR Report Key | 1070009 |
| Report Source | 05 |
| Date Received | 2008-07-02 |
| Date of Report | 2008-06-03 |
| Date of Event | 2008-02-29 |
| Date Mfgr Received | 2008-06-03 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2009-11-17 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOE FALVO |
| Manufacturer Street | 100 INDIGO CREEK DR |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854535735 |
| 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 BARB REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DIS |
| Date Received | 2008-07-02 |
| Model Number | NA |
| Catalog Number | 680 1988 |
| Lot Number | 1522-01-7678 |
| ID Number | NA |
| Device Expiration Date | 2008-10-01 |
| 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 DR ROCHESTER NY 14626510 US 14626 5101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-02 |