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 2018-02-06 for COC THC MOP AMP MAMP BZO BAR MTD MDMA OX DOA-1127 manufactured by Alere San Diego, Inc..
[99789666]
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 expected negative results at read time for all analytes including amp, mamp, mop, coc, and thc. 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. A capa, capa-(b)(4), has been initiated to address the late documentation of this case.
Patient Sequence No: 1, Text Type: N, H10
[99789667]
The customer reported receiving positive results using the multi-drug 12 panel key cup for multiple analytes as compared to negative results received at the laboratory between september 2017 and december 2017. The customer reported the issue was isolated to a single patient. Although the customer was unable to confirm the specific issue observed, pictures were submitted showing positive results for amp, mamp, coc, mop, and thc using the multi-drug 12 panel key cup. Although requested, no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2018-00017 |
| MDR Report Key | 7245041 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-02-06 |
| Date of Report | 2018-02-06 |
| Date Mfgr Received | 2017-12-12 |
| Date Added to Maude | 2018-02-06 |
| 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 | COC THC MOP AMP MAMP BZO BAR MTD MDMA OX |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2018-02-06 |
| Returned To Mfg | 2018-01-19 |
| Model Number | DOA-1127 |
| Lot Number | DOA7050432 |
| Device Expiration Date | 2019-04-30 |
| 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 | 2018-02-06 |