MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-26 for SIGNIFY ER DRUG SCREEN 1P4825 manufactured by Alere San Diego, Inc..
[24820036]
Investigation conclusion: investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[24820037]
Customer reporting false positive coc. Patient tested positive for coc. The test line was reported to be faint. The same urine sample was tested subsequently using the iscreen drug test. The result was "very negative". No reported adverse patient sequela. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
[33033346]
Investigation conclusion update: customer's observation was not replicated in-house with retention and return product. Retention and return products were tested with in-house drug-free donor urine, all coc results were negative at read time and met qc specification. No false positive 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
| Report Number | 2027969-2015-00625 |
| MDR Report Key | 5032284 |
| Date Received | 2015-08-26 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-07-30 |
| Date Mfgr Received | 2015-10-02 |
| Date Added to Maude | 2015-08-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SIGNIFY ER DRUG SCREEN |
| Generic Name | ER DRUG SCREEN |
| Product Code | DKZ |
| Date Received | 2015-08-26 |
| Returned To Mfg | 2015-09-10 |
| Model Number | 1P4825 |
| Lot Number | DOA5070050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2015-08-26 |