MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2017-02-10 for TRIAGE PROFILER SOB PANEL 97300EU manufactured by Alere San Diego, Inc..
[67259956]
Investigation conclusion: customer's complaint was not replicated with in-house testing of retain lot w61602b. No issues with ckmb or myo recovery were observed. Manufacturing batch records for lot w61602b were reviewed and found that the lot met release specifications. Based on the information available, there is no indication of a product deficiency and no corrective action is required. Although this catalog number (97300eu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 97300, 510(k) number k080269.
Patient Sequence No: 1, Text Type: N, H10
[67259957]
The following events occurred in (b)(6): discrepant low sob panel results as compared to cardiac panel results using a whole blood sample. Ckmb: sob panel= 3. 2 ng/ml and cardiac panel= 7. 5 ng/ml (normal range= 0-4. 3 ng/ml) myoglobin: sob panel= 180 ng/ml and cardiac panel= 336 ng/ml (normal range= 0-170 ng/ml). Ekg diagnosis was acute ischemic cardiomyopathy and acute congestive heart failure. The diagnosis of the patient was non-insulin dependent diabetes mellitus with other complications, primary essential hypertension, and congestive heart failure. The treatment for the patient was ambulatory with enalapril, acetil salicylic acid, citorvastatin, insulin, metformin and glybenclamid. The treatment of the patient was based on cardiac panel results and not the questioned sob panel results. The customer later performed the testing with plasma and the reported receiving a closer correlation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00031 |
| MDR Report Key | 6323871 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-02-10 |
| Date of Report | 2017-01-12 |
| Date of Event | 2016-12-31 |
| Date Mfgr Received | 2017-01-12 |
| Date Added to Maude | 2017-02-10 |
| 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 | 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 | TRIAGE PROFILER SOB PANEL |
| Generic Name | CARDIOPROFILER PANEL |
| Product Code | DAP |
| Date Received | 2017-02-10 |
| Catalog Number | 97300EU |
| Lot Number | W61602B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-02-10 |