MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-06-13 for VITROS CHEMISTRY PRODUCTS CRBM SLIDES 8892382 manufactured by Ortho-clinical Diagnostics.
[15446517]
The customer observed positively biased crbm results on multiple pt samples on both the vitros 950 and 5. 1 fs analyzers during a correlation study. Biased results of the magnitude and direction observed may lead ot inappropriate physician action. No biased pt results were reported, and there was no report of pt harm as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319809-2005-00138 |
| MDR Report Key | 613211 |
| Report Source | 05 |
| Date Received | 2005-06-13 |
| Date of Report | 2005-05-16 |
| Date of Event | 2005-05-16 |
| Date Mfgr Received | 2005-05-16 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2005-06-15 |
| 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 | THOMAS SMITH |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 146261501 |
| Manufacturer Country | US |
| Manufacturer Postal | 146261501 |
| Manufacturer Phone | 5854533735 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1319809-06/08/05-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CRBM SLIDES |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | KLT |
| Date Received | 2005-06-13 |
| Model Number | NA |
| Catalog Number | 8892382 |
| Lot Number | 3921-0023-5536 |
| ID Number | NA |
| Device Expiration Date | 2005-11-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 603039 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 146265101 US |
| Baseline Brand Name | VITROS CHEMISTRY PRODUCTS CRBM SLIDES |
| Baseline Generic Name | IN VITRO DIAGNOSTIC (CARBAMAZEPINE) |
| Baseline Model No | NA |
| Baseline Catalog No | 8892382 |
| Baseline ID | NA |
| Baseline Device Family | VITROS CHEMISTRY SLIDES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 8 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K980283 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-13 |