MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-02-26 for (COC/AMP/EDDP100/MOP/BZO)MULTI-DRUG ONE STEP 5 DRUG SCREEN TEST PANEL (URINE) DOA-154-1661-XA-ONC536B manufactured by Alere San Diego, Inc..
[39209899]
Investigation conclusion: customer's observation was not replicated in-house with retention devices. Retention devices were tested with in-house drug free donor urine; all coc results were negative at 5 min read time. No false positive 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. No corrective action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[39209900]
Customer alleging receiving false positive coc, alternative method negative results. Event occurred in (b)(6). Alternate testing method not provided. Coc was compared against another rapid test from another company, which showed negative results. No reported adverse patient sequela.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2016-00120 |
| MDR Report Key | 5464681 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-02-26 |
| Date of Report | 2016-02-02 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2016-02-02 |
| Date Added to Maude | 2016-02-26 |
| 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 | (COC/AMP/EDDP100/MOP/BZO)MULTI-DRUG ONE STEP 5 DRUG SCREEN TEST PANEL (URINE) |
| Generic Name | DRUG OF ABUSE TEST |
| Product Code | DKZ |
| Date Received | 2016-02-26 |
| Model Number | DOA-154-1661-XA-ONC536B |
| Lot Number | DN-DOA5070775 |
| 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 | 2016-02-26 |