MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-07-13 for ORTHO BRAIN THROMBOPLASTIN 732470 manufactured by Ortho-clinical Diagnostics.
[18191273]
The customer reported that obt348 did not reconstitute well and was giving prolonged clotting times. If quality control testing is not properly performed prior to using a discolored vial of obt348 to test patient samples, erroneous pt clotting times and/or inr values may be reported. This corresponds to ortho-clinical diagnostics complaint number, 98-00131-01.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-1998-00090 |
| MDR Report Key | 177283 |
| Report Source | 05 |
| Date Received | 1998-07-13 |
| Date of Report | 1998-07-10 |
| Date of Event | 1998-01-12 |
| Date Mfgr Received | 1998-01-12 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 1998-07-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO BRAIN THROMBOPLASTIN |
| Generic Name | PROTHROMBIN TIME TEST |
| Product Code | GFO |
| Date Received | 1998-07-13 |
| Model Number | NA |
| Catalog Number | 732470 |
| Lot Number | OBT348 |
| ID Number | NA |
| Device Expiration Date | 2000-08-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 172387 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 1001 US HWY 202 RARITAN NJ 08869 US |
| Baseline Brand Name | ORTHO BRAIN THROMBOPLASTIN |
| Baseline Generic Name | PROTHROMBIN TIME REAGENT |
| Baseline Model No | NA |
| Baseline Catalog No | 732470 |
| Baseline ID | PROTHROMBIN TIM |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-13 |