MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-24 for PHD 1X IFA/EIA SYSTEM 426-0400 manufactured by Bio-rad Laboratories, Inc..
[21178128]
A physician contacted the user facility after receiving what he thought were incorrect results for (b)(6). The patients were greater than 90% negative. The literature and product labeling (instructions for use) have an expected positivity rate of 97-98%. The lab uses non-technical personnel performing the testing and a cls had released the results. The lab routinely performs (b)(6) together. The (b)(6) results did not generate any complaints. The reader at the customer site was the pr4100 model. The customer pulled sample run reports on the system from (b)(6) and contacted ussd technical support with several suspect runs as well as indicating that the (b)(6) assay was not always passing validation rules and resulted in routinely failing runs with no results reported. Samples from previous suspect runs were available for repeat testing. When they were repeated in a (b)(6) only run, without (b)(6), the run passed validation rules and the (b)(6) results were greater than 90% positive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950880-2014-00001 |
| MDR Report Key | 4213347 |
| Report Source | 07 |
| Date Received | 2014-10-24 |
| Date of Report | 2014-10-24 |
| Date of Event | 2014-09-25 |
| Date Mfgr Received | 2014-09-25 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-11-14 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA KLIMLEY |
| Manufacturer Street | 5500 EAST 2ND ST. |
| Manufacturer City | BENICIA CA 94510 |
| Manufacturer Country | US |
| Manufacturer Postal | 94510 |
| Manufacturer Phone | 5107416263 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHD 1X IFA/EIA SYSTEM |
| Generic Name | PHD 1X |
| Product Code | JJI |
| Date Received | 2014-10-24 |
| Model Number | PHD 1X |
| Catalog Number | 426-0400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES, INC. |
| Manufacturer Address | 4000 ALFRED NOBEL DR. HERCULES CA 94547 US 94547 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-24 |