MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-07-07 for 5 PANEL INTEGRATED CUP (DOA-1257-19) DOA-1257-19-ONW02B manufactured by Alere San Diego, Inc..
[49034951]
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 thc, coc, amp, met and opi results were negative at 5 min read time and met qc specification. No false positive results were obtained. Manufacturing batch record review did not uncover any abnormalities. Root cause could not be determined base on the information provided. Based on the information available, there is no indication of a product deficiency. Due to increase of faint line/false positive thc complaint issue, (b)(4) initiated capa (b)(4). This issue will be subject to tracking and trending.
Patient Sequence No: 1, Text Type: N, H10
[49034952]
Customer alleging receiving false positive test results for drugs. Customer alleges they received negative blood work results. Customer did not specify what the specific test results were for. Although requested, no additional information was received. No patient information provided. No adverse patient sequela reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2016-00495 |
| MDR Report Key | 5776909 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-07-07 |
| Date of Report | 2016-06-07 |
| Date of Event | 2016-06-05 |
| Date Mfgr Received | 2016-06-07 |
| Date Added to Maude | 2016-07-07 |
| 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 | 5 PANEL INTEGRATED CUP (DOA-1257-19) |
| Generic Name | DRUG OF ABUSE TEST |
| Product Code | DKZ |
| Date Received | 2016-07-07 |
| Model Number | DOA-1257-19-ONW02B |
| Lot Number | DOA5060630 |
| 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 | 2016-07-07 |