MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-26 for TRIAGE TOX DRUG SCREEN WITH MTD 94400 manufactured by Biosite Incorporated.
[19246450]
Customer reported a false negative apap result on triage tox drug screen with mtd. Customer ran four tests on one pt urine sample and obtained the following results: w45876b: +apap fresh urine. W46864b: -apap urine was cold after refrigeration. W45876b: +apap urine at room temp > 30 min. W46864b: +apap urine at room temp > 30 min. Customer used two different strip lots and had the same results on three different meters (42699, 40679 and 47056). Qc samples tested on both lots of strips with correct results. +apap is reported for this pt. Tech support checked with the tech who ran the test and she ran the urine right from the refrigerator (the negative result). She waited about a half hour and repeated, all results verified.
Patient Sequence No: 1, Text Type: D, B5
[19344494]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2010-00365 |
| MDR Report Key | 1648917 |
| Report Source | 05,06 |
| Date Received | 2010-03-26 |
| Date of Report | 2010-03-26 |
| Date of Event | 2010-03-03 |
| Date Mfgr Received | 2010-03-03 |
| Date Added to Maude | 2010-05-04 |
| 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 | 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 | 2010-03-26 |
| Model Number | 94400 |
| Catalog Number | 94400 |
| Lot Number | W46864B |
| ID Number | W45876B |
| 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 | 2010-03-26 |