MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-09-16 for MULTI-LINE 10 DRUG WITH CUP DOA-1107-051-08A-ONW24A manufactured by Alere San Diego, Inc..
[26031408]
Investigation conclusion: customer's observation was not replicated in-house with retention product. Retention products were tested with 29 samples of drug-free donor urine, all coc results were negative at read time. No coc false positive were obtained. Manufacturing batch record review did not uncover any abnormalities. Root cause could not be determined from the information provided. Based on the information available, there is no indication of a product deficiency. No corrective action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[26031409]
Customer alleging receiving false positive test results for coc for 7 devices. "client states that the 10 panel icup is having false positive for coc on donor urine specimen. The client ordered a total of 50 devices, the first box worked as intended. When testing random donors using the second box, all seven devices used were positive for coc. All tests showed no line develop in the test region for coc on random different fresh donor urine specimens. Presumptive positives were sent to an unknown laboratory for confirmation testing and were reported out as negative. " no images or test reports were available. No additional or patient information provided. No adverse patient sequela reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2015-00677 |
| MDR Report Key | 5082580 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-09-16 |
| Date of Report | 2015-08-18 |
| Date of Event | 2015-08-18 |
| Date Mfgr Received | 2015-08-18 |
| Date Added to Maude | 2015-09-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI-LINE 10 DRUG WITH CUP |
| Generic Name | DRUG OF ABUSE TEST |
| Product Code | DKZ |
| Date Received | 2015-09-16 |
| Model Number | DOA-1107-051-08A-ONW24A |
| Lot Number | DOA4090547 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-16 |