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 2018-03-23 for KIT, TRIAGE, CARDIAC TNI/CKMB 97022HS manufactured by Quidel Cardiovascular, Inc..
[103792083]
Investigation conclusion: the customer's complaint was not replicated with in-house testing of retain lot w63532rb. No issues with ckmb recovery were observed. Manufacturing batch records for lot w63532rb were reviewed and found that the lot met final release specifications. The customer returned the two patient draws associated with the reported discrepancy. Testing of the patient sample returns on retains of device lot w63532rb did not replicate customers complaints. All ckmb results for the patient draws were below customers cut-off of 4. 3ng/ml. Unable to replicate or determine root cause of customers reported discrepant high ckmb result. Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Patient Sequence No: 1, Text Type: N, H10
[103792084]
Customer reported imprecision results for ckmb on triage lot number w63532rb for a patient. On (b)(6) 2018, patient was tested and the following results were received: 7:30am: sample 1, resulted ckmb 5. 3ng/ml; 10:30am: sample 2, redraw (new device) resulted ckmb 3. 0ng/ml customers ckmb cut-off: 4. 3ng/ml. Patient was administered heparin bolus followed by a heparin drip prior to the 10:30am draw and result. Patient outcome: flare up of chf with no mi. Patient is doing well in skilled bed at this time. Customer provided additional information on 2/27/2018 of their repeat testing for the two patient draws: repeat testing: sample 1 (same tube of 7:30am draw) using plasma resulted ckmb=4. 4. Sample 2 (same tube of 10:30am draw) using plasma resulted ckmb=3. 2, (3) sample 2 (same tube of 10:30am draw) using wb resulted ckmb=2. 7. There is no information to suggest the triage ckmb result of 5. 3ng/ml altered patient treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013982035-2018-00007 |
| MDR Report Key | 7367239 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-03-23 |
| Date of Report | 2018-03-23 |
| Date of Event | 2018-02-22 |
| Date Mfgr Received | 2018-02-22 |
| Device Manufacturer Date | 2017-08-22 |
| Date Added to Maude | 2018-03-23 |
| 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 | 2018-03-23 |
| Returned To Mfg | 2018-03-08 |
| Model Number | 97022HS |
| Lot Number | W63532RB |
| Device Expiration Date | 2018-05-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-03-23 |