MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-18 for TRIAGE + TCA 25 TEST 92000 manufactured by Alere San Diego Inc.
[19973232]
Customer reported potential (b)(6) coc on two samples with triage + tca 25 test vs. Confirmatory testing. Two samples were taken from a female patient who delivered a baby by c-section. Samples were collected (b)(6) 2014. Ran the first sample before c-section, collected at 1630. Re-collected a second sample and ran after c-section, collected at 1810. The patient tested positive for coc with the triage + tca 25 test. Coc did not test positive on the confirmation testing that was performed.
Patient Sequence No: 1, Text Type: D, B5
[20261876]
No discrepant or positive results were observed with any devices tested. No device issues or errors were observed with any device tested. No patient sample was returned for testing. Patient sample interference cannot be ruled out as a potential cause for discrepant results. No product deficiency was established. No corrective action required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2014-00134 |
| MDR Report Key | 3822927 |
| Report Source | 05 |
| Date Received | 2014-02-18 |
| Date of Report | 2014-02-12 |
| Date of Event | 2014-01-30 |
| Date Mfgr Received | 2014-02-12 |
| Date Added to Maude | 2014-06-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| 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 | TRIAGE + TCA 25 TEST |
| Generic Name | DRUG OF ABUSE TEST |
| Product Code | DKZ |
| Date Received | 2014-02-18 |
| Model Number | 92000 |
| Lot Number | 326218 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO INC |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-18 |