MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-06-29 for TRIAGE PROFILER SOB 25 TEST KIT 97300 manufactured by Biosite Incorporated.
[1133067]
Customer is having correlation issues (false negative result) for ckmb when testing triage profiler sob 25 test kit on triage meter vs. Lab corp. Customer doing correlation study for sob and received discrepant results. Some results for ckmb are negative using triage meter and are positive using lab corp. Cut off for ckmb for triage is 4. 3 and cut off for lab corp is 2. 9. No clinical information provided for patient and correlation was run using multiple lots.
Patient Sequence No: 1, Text Type: D, B5
[8280477]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2009-00512 |
| MDR Report Key | 1462212 |
| Report Source | 05,07 |
| Date Received | 2009-06-29 |
| Date of Report | 2009-06-26 |
| Date of Event | 2009-06-08 |
| Date Mfgr Received | 2009-06-08 |
| Date Added to Maude | 2010-07-21 |
| 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, MGR. |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE PROFILER SOB 25 TEST KIT |
| Generic Name | CARDIAC MARKER TEST |
| Product Code | JHF |
| Date Received | 2009-06-29 |
| Model Number | 97300 |
| Catalog Number | 97300 |
| Lot Number | W43959 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2009-06-29 |