MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-05-05 for TRIAGE TOX DRUG SCREEN WITH MTD 94400 manufactured by Biosite Incorporated.
[1498377]
Caller reported a potential false negative apap result when testing frozen urine sample on different meters and device lot numbers. Customer obtained potential false negative apap result x6 frozen urine sample on different meters using device lot number w47200. The customer tested and observed positive apap x4 when using device lot number w46864. Customer called back to state that a (b)(6) male went into the er. Er admitting diagnosis unk; discharged; prescription and otc medications unk. Controls were run and passed.
Patient Sequence No: 1, Text Type: D, B5
[8469825]
Investigation in process. Additional serial: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2010-00547 |
| MDR Report Key | 1678408 |
| Report Source | 06 |
| Date Received | 2010-05-05 |
| Date of Report | 2010-05-05 |
| Date of Event | 2010-04-15 |
| Date Mfgr Received | 2010-04-15 |
| Date Added to Maude | 2012-11-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CARMEN BERGELIN, MANAGER |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE TOX DRUG SCREEN WITH MTD |
| Generic Name | TOX DRUG SCREEN |
| Product Code | DJR |
| Date Received | 2010-05-05 |
| Model Number | 94400 |
| Lot Number | W46864 |
| ID Number | W47200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSITE INCORPORATED |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-05 |