MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-29 for HENRY SCHIN H PYLORI manufactured by Inverness.
[14964924]
I was using henry schein h pylori kit for my proficiency testing. I got negative for both samples. Sample hpy-03 should have been positive. I performed my proficiency samples on a clarity h. Pylori kit and got positive for hpy-03. This has been reported to the henry schein sales rep and to (b)(4). The henry schein kit has been replaced with the clarity h pylori kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016567 |
| MDR Report Key | 1744471 |
| Date Received | 2010-06-29 |
| Date of Report | 2010-06-28 |
| Date of Event | 2010-05-19 |
| Date Added to Maude | 2010-07-06 |
| 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 | 3 |
| 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 | HENRY SCHIN H PYLORI |
| Generic Name | H PYLORI KIT |
| Product Code | LYR |
| Date Received | 2010-06-29 |
| Returned To Mfg | 2010-06-23 |
| Lot Number | HP9110019 |
| Device Expiration Date | 2011-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVERNESS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-29 |