MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-21 for ACCUTEST (PF364) manufactured by .
[4182147]
Serum hcg test was weakly positive on (b)(6) 2014. Performed using accutest kit lot suo1183m5 exp 01/2015. New specimen recollected and tested on (b)(6) 2014. This second specimen was also weakly positive with accutest kit. Specimen was then tested with sure-vue and osom kits and was found to be negative using these kits. (b)(6). We have experienced at least 4 instances of false positive hcg (both serum and urine) with the accutest kits. We previously filed an adverse event report to the fda in (b)(6) 2014 concerning this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034691 |
| MDR Report Key | 3647119 |
| Date Received | 2014-02-21 |
| Date of Report | 2014-02-07 |
| Date of Event | 2014-02-07 |
| Date Added to Maude | 2014-02-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUTEST (PF364) |
| Generic Name | ACCUTEST (PF364) |
| Product Code | LCX |
| Date Received | 2014-02-21 |
| Lot Number | SUO1183M5 |
| Device Expiration Date | 2015-01-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-21 |