MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2017-04-02 for ICUP 5-DRUG INT. CUP W/ADULT. STRIP DUA-157 manufactured by Alere San Diego, Inc..
[71501940]
Investigation conclusion: the customer's observation was not replicated in-house with retention and return products. Retention and return devices were tested with in-house drug free donor urine and all devices showed negative results for thc and coc analytes at read time and met qc specifications. No false positive results were observed during in-house testing. Manufacturing batch record review did not uncover any abnormalities. Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Patient Sequence No: 1, Text Type: N, H10
[71501941]
The customer reported receiving one unconfirmed false positive thc result on one donor urine specimen and one unconfirmed false positive cocaine result on another donor urine specimen. The unconfirmed false positive results occurred on 2 devices out of 25 devices used. No confirmation testing was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00061 |
| MDR Report Key | 6451982 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-04-02 |
| Date of Report | 2017-03-03 |
| Date Mfgr Received | 2017-03-03 |
| Date Added to Maude | 2017-04-02 |
| 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 | ICUP 5-DRUG INT. CUP W/ADULT. STRIP |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2017-04-02 |
| Returned To Mfg | 2017-03-22 |
| Model Number | DUA-157 |
| Lot Number | DOA6050024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-04-02 |