MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-05-26 for ACS:180 THEOPHYLLINE 672285, 672286 manufactured by Bayer Diagnostics.
[125812]
Initial field reports received in 1/99 suggested low control recoveries of the acs:180 theophylline assay resulting in an internal investigation. Initial studies were inconclusive. Subsequent internal testing reported in april 1999 indicated that certain acs:180 assays when run in random access with acs:180 theophylline caused depressed theophylline values. The shift in values can be summarized as follows: assay - ckmb, effect on theo - -5 to -10%; assay - digoxin, effect on theo - -3% to -10%; assay - prge, effect on theo - -3% to -5%; assay - gi, effect on theo - -3% to -8%; assay - lh2, effect on theo - -5% to -7%; assay - ckmb ii, effect on theo - -12% to -20%; assay - estradiol, effect on theo - -6%; assay - t4, effect on theo - -3% to -13%; and assay - tsh3, effect on theo - -2% to -6%. The acs:180 theophylline assay continues to meet its performance claims when run in batch mode. There were no adverse events including serious injuries or deaths associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-1999-00001 |
| MDR Report Key | 226688 |
| Report Source | 07 |
| Date Received | 1999-05-26 |
| Date of Report | 1999-01-01 |
| Date Added to Maude | 1999-06-14 |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACS:180 THEOPHYLLINE |
| Generic Name | IMMUNOASSAY |
| Product Code | LGS |
| Date Received | 1999-05-26 |
| Model Number | NA |
| Catalog Number | 672285, 672286 |
| Lot Number | ALL LOTS |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 219824 |
| Manufacturer | BAYER DIAGNOSTICS |
| Manufacturer Address | 333 CONEY ST E. WALPOLE MA 020321597 US |
| Baseline Brand Name | ACS:180 THEOPHYLLINE |
| Baseline Generic Name | THEOPHYLLINE IMMUNOASSAY |
| Baseline Model No | NA |
| Baseline Catalog No | 672285 |
| Baseline ID | NA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 9 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K951169 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-05-26 |