MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-07-22 for ABBOTT AXSYM SYSTEM manufactured by Abbott Manufacturing Inc.
[140808]
Customer experiencing erratic results with valproic acid. On 6/23/99 customer obtained a result of 0. 56ug/ml. Result was questioned by physician, sample was rerun with a result of 75. Oug/ml. Customer is not sure if tube contained fibrin. No report of impact to patient.
Patient Sequence No: 1, Text Type: D, B5
[6360802]
Customer obtained a valproic acid result of 7. 9ug/ml, result was questioned by physician. Sample was rerun with a result of 66. 9ug/ml. Physician questioned result prior to treating patient. No report of injury.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | 1628664-1999-00039 |
| MDR Report Key | 233291 |
| Report Source | 06 |
| Date Received | 1999-07-22 |
| Date of Report | 1999-07-21 |
| Date of Event | 1999-06-23 |
| Date Mfgr Received | 1999-06-28 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 1999-07-29 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT AXSYM SYSTEM |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | LCI |
| Date Received | 1999-07-22 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 226131 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DR. IRVING TX 75038 US |
| Baseline Brand Name | ABBOTT AXSYM SYSTEM |
| Baseline Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Baseline Model No | NA |
| Baseline Catalog No | 7A83-01 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-07-22 | |
| 2 | 0 | 1999-07-22 |