MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-09-11 for TDXFLX SYSTEM 4A24-96 manufactured by Abbott Manufacturing, Inc..
[121014]
On or around 8/14/98, an error code "sample level hi" was printed on the data tape when an amniotic fluid sample was initially tested for tdxflx flm ii. The operator reported the result as "hi. " the initial testing was performed on a fresh sample. The sample was retested giving a result of 17. 7/17. 7 mg/g. The retest was performed on a frozen sample. The infant was in a breech position. While the physician was attempting to change the infant's position, the mother went into labor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-1998-00080 |
| MDR Report Key | 187240 |
| Report Source | 05,06 |
| Date Received | 1998-09-11 |
| Date of Report | 1998-09-10 |
| Date of Event | 1998-08-14 |
| Date Mfgr Received | 1998-08-14 |
| Device Manufacturer Date | 1991-05-01 |
| Date Added to Maude | 1998-09-16 |
| 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 | TDXFLX SYSTEM |
| Generic Name | AUTOMATED FPIA ANALYZER |
| Product Code | LCQ |
| Date Received | 1998-09-11 |
| Model Number | NA |
| Catalog Number | 4A24-96 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 182006 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DR. IRVING TX 75038 US |
| Baseline Brand Name | TDXFLX FPIA ANALYZER - REBURB |
| Baseline Generic Name | AUTOMATED FPIA ANALYZER |
| Baseline Model No | NA |
| Baseline Catalog No | 4A24-96 |
| Baseline ID | NA |
| Baseline Device Family | TDX AND TDXFLX SYSTEMS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K904226 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-09-11 |