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 2018-05-04 for KIT, TRIAGE, CARDIAC TNI/CKMB 97022HS manufactured by Quidel Cardiovascular, Inc..
[107998680]
Investigation conclusion: the customers complaint was not replicated during in-house testing of retain lot w63552rb with whole blood donors and in-house samples. Testing found no issues with product performance; no discordant ckmb results were observed. Manufacturing batch records for lot w63552rb were reviewed and found that the lot met final release specifications. No issues with ckmb recovery observed. The device was not returned for evaluation; however, patient sample was returned. Observed elevated ckmb results with the returned patient sample. Hama interference testing was inconclusive. The returned patient sample was observed to be severely hemolyzed. Although hama interference testing was inconclusive, additional sample specific factors/interference in the returned sample cannot be ruled out as the cause of the complaint. Based on the information available, there is no indication of a product deficiency and no corrective action is required. This event is related to mdr 3013982035-2018-00011.
Patient Sequence No: 1, Text Type: N, H10
[107998681]
Customer reported discordant results for ckmb on triage compared to the beckman dxi analyzer. Patient presented to the urgent room for dizziness. Patient sample was run on triage lot number w63552rb and resulted with ckmb of 38. 7 ng/ml. The patient sample was tested on the beckman dxi analyzer with a ckmb result of 3. 8 ng/ml. Sample was repeated on the dxi and yielded ckmb result of 4. 0 ng/ml. Customer provided the dxi cut-off of 6. 4 ng/ml. The patient sample was retested on an alternate triage device lot 3 days later and the result was similar to the original triage result. Mdr 3013982035-2018-00011 captures this event. Customer stated the patient was admitted to the hospital for observation. Customer stated no treatment was given to the patient based on triage result and that the patient encountered no harm. There was no report of adverse health consequences due to the discordant ckmb result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00010 |
| MDR Report Key | 7489084 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-05-04 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-04-06 |
| Date Mfgr Received | 2018-04-09 |
| Device Manufacturer Date | 2017-10-03 |
| Date Added to Maude | 2018-05-04 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JESSICA PERROTTE |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588053573 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIT, TRIAGE, CARDIAC TNI/CKMB |
| Generic Name | KIT, TRIAGE, CARDIAC TNI/CKMB |
| Product Code | JHX |
| Date Received | 2018-05-04 |
| Model Number | 97022HS |
| Lot Number | W63552RB |
| Device Expiration Date | 2018-06-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CARDIOVASCULAR, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-04 |