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 2018-02-26 for RED -MLTI-DRG 6 PNL SCRN TST (DOA-164) manufactured by Alere San Diego, Inc..
[101250870]
Investigation conclusion: the customer's observation was not replicated in-house with retention products. Retention devices were tested with in-house drug-free donor urine and all devices showed expected negative results; all coc, met, thc, mop, oxy, and bzo strips yielded correct negative results at read time. No false positive results were observed during in-house testing. Manufacturing batch record review did not uncover any abnormalities. The device provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Based on the information available, there is no indication of a product deficiency. A capa, capa (b)(4), has been opened to address the late escalation of this complaint.
Patient Sequence No: 1, Text Type: N, H10
[101250871]
The customer reported receiving unconfirmed false positive results for all analytes using the multi-drug one step 6 drug screen test panel. The unconfirmed false positive results occurred on different random donors. The unconfirmed false positive results occurred on 23 devices out of 25 devices used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2018-00025 |
| MDR Report Key | 7298223 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-02-26 |
| Date of Report | 2018-02-26 |
| Date Mfgr Received | 2018-01-09 |
| Date Added to Maude | 2018-02-26 |
| 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 | RED -MLTI-DRG 6 PNL SCRN TST (DOA-164) |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2018-02-26 |
| Model Number | DOA-164 |
| Lot Number | DOA6090545 |
| Device Expiration Date | 2018-08-31 |
| 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 | 2018-02-26 |