MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-06 for TARGET HCG URINE CONTROL SET 30-0103 manufactured by Myers-stevens Group.
[4694542]
On (b)(6) /2014 a point of care testing user at (b)(6) medical center,(b)(6) reported urine hcg quality control results were testing opposite of their intended reactions. The qc bottles were retested in the clinical laboratory and results confirmed. Reported deviation to the manufacturer on (b)(6) 2014. We were instructed to return the kit and replacement material would be shipped to our facility. According to the manufacturer there had been no other incidents of this nature reported. On (b)(6) 2014 one of our other facilities, (b)(6) hospital experienced the same deviation in the clinical laboratory. The testing was repeated and results were confirmed. The manufacturer was contacted again. The contact person still claimed that no other incidents of this kind had been reported. Replacement kits received. Additional lot numbers available on site at each facility for qc testing, these lots were obtaining the expected results. As no time was pt care in jeopardy or qc not performed. Event reappeared after reintroduction: #1 and #2: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037694 |
| MDR Report Key | 3999725 |
| Date Received | 2014-08-06 |
| Date of Report | 2014-08-04 |
| Date of Event | 2014-07-02 |
| Date Added to Maude | 2014-08-13 |
| 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 | TARGET HCG URINE CONTROL SET |
| Generic Name | TARGET HCG URINE CONTROL SET |
| Product Code | JHJ |
| Date Received | 2014-08-06 |
| Returned To Mfg | 2014-07-09 |
| Catalog Number | 30-0103 |
| Lot Number | 0103401-C1RP |
| Device Expiration Date | 2016-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MYERS-STEVENS GROUP |
| Manufacturer Address | MONTEBELLO CA US |
| Brand Name | TARGET HCG URINE CONTROL SET |
| Generic Name | TARGET HCG URINE CONTROL SET |
| Product Code | JHJ |
| Date Received | 2014-08-06 |
| Returned To Mfg | 2014-07-09 |
| Catalog Number | 30-0103 |
| Lot Number | 20103401-E1R0 |
| Device Expiration Date | 2017-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MYERS-STEVENS GROUP |
| Manufacturer Address | MONTEBELLO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-06 |