MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-03 for TDX/TDXFLX FLM II 7A76-50 manufactured by Abbott Laboratories.
[666249]
The customer stated that a barcode misread on the tdx/tdxflxflm ii reagent pack. A calibration was performed using a flm ii reagent pack but upon review of the calibration, they noted ethosuximide was calibrated instead of flm ii. The abbott customer technical advocate had the customer clean the reagent barcode and the barcode reader to resolve the issue. No patient results were generated and there was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[8127868]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2007-00205 |
| MDR Report Key | 889966 |
| Report Source | 05 |
| Date Received | 2007-08-03 |
| Date of Report | 2007-07-05 |
| Date of Event | 2007-07-05 |
| Date Mfgr Received | 2007-07-05 |
| Date Added to Maude | 2007-09-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDX/TDXFLX FLM II |
| Generic Name | FPA FOR THE ASSESSMENT OF LUNG MATURITY OF THE FETUS |
| Product Code | JHF |
| Date Received | 2007-08-03 |
| Model Number | NA |
| Catalog Number | 7A76-50 |
| Lot Number | 51325M200 |
| ID Number | NA |
| Device Expiration Date | 2007-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 876569 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-03 |