MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-28 for UNSPECIFIED LATERAL FLOW DRUG SCREEN DOA-1124-031-A-ONC01B manufactured by Alere San Diego, Inc..
[59012795]
Investigation conclusion: investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[59012796]
Event occurred in (b)(6). Report received of discrepant unspecified false positive results. Customer alleging the tests have been very difficult to interpret as 100 in 120 used tests showed additional red line within t- and/ or c-line. Some of the tests showed false positive results in addition. Unfortunately the customer used all her tests up and did not document anything else. No additional information provided. No reported adverse patient sequela.
Patient Sequence No: 1, Text Type: D, B5
[60919086]
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 negative results for all analytes at read time and met qc specifications. No false positive results were observed. Manufacturing batch record review did not uncover any abnormalities. Root cause could not be determined based on 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
| Report Number | 2027969-2016-00666 |
| MDR Report Key | 6064296 |
| Date Received | 2016-10-28 |
| Date of Report | 2016-09-29 |
| Date of Event | 2016-08-22 |
| Date Mfgr Received | 2016-11-17 |
| Date Added to Maude | 2016-10-28 |
| 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 | UNSPECIFIED LATERAL FLOW DRUG SCREEN |
| Generic Name | DRUG OF ABUSE TEST |
| Product Code | DKZ |
| Date Received | 2016-10-28 |
| Model Number | DOA-1124-031-A-ONC01B |
| Lot Number | DOA5100279 |
| Device Expiration Date | 2017-07-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-10-28 |