MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-30 for ALERE TOX SCREEN DRUG CUP 4027750131 manufactured by Alere San Diego, Inc..
[4606515]
Caller alleging a false positive for all drugs including cocaine (coc). Caller stated a test would be run on one cup and get one result; then the specimen in a different cup would get a different result.
Patient Sequence No: 1, Text Type: D, B5
[12150961]
Customer's observation was not replicated in-house with retention strips. Retention strip were tested 29 drug-free donor urine; all met/thc/opi/ppx/bar/coc/oxy/bzo/mdma results were negative. No false results 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. This issue will be subject to tracking and trending. As there was no indication of a product deficiency, corrective action is not required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2014-00517 |
| MDR Report Key | 3963493 |
| Report Source | 05 |
| Date Received | 2014-05-30 |
| Date of Report | 2014-05-12 |
| Date of Event | 2014-05-12 |
| Date Mfgr Received | 2014-05-12 |
| Date Added to Maude | 2014-08-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| 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 | ALERE TOX SCREEN DRUG CUP |
| Generic Name | DRUGS OF ABUSE |
| Product Code | DKZ |
| Date Received | 2014-05-30 |
| Model Number | 4027750131 |
| Lot Number | DOA3090335 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-30 |