MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-30 for TRIAGE CARDIAC TRIPLE MARKER PANEL 97000HSEU manufactured by Alere San Diego, Inc..
[61452147]
Investigation conclusion: investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[61452148]
Report received of discrepant results for troponin i at a patient clinic. Event occurred in (b)(6). Patient # 3 below had a positive result for troponin i, but the follow was a negative result. On (b)(6) 2016 11:57 result: 0. 17 cpk:45 ckmb: 12. On (b)(6) 2016 13:35 result: <0. 05 cpk:44 ckmb: 10. Ecg normal parameters. Optic check ok. No reported adverse patient sequela. This discordant results only appear for troponin i. The other cardiac enzymes results were coherent with patient clinic. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
[63284453]
Investigation/conclusion: customer's complaint was not replicated with in-house testing of retain lot w62034. No issues with tni recovery were observed. Manufacturing batch records for lot w62034 were reviewed and found that the lot met release specifications. Further investigation was not possible since the customer did not return any samples for testing. Unable to determine a root cause from the available information. Product deficiency was not established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2016-00698 |
| MDR Report Key | 6135713 |
| Date Received | 2016-11-30 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-11-12 |
| Date Mfgr Received | 2016-12-02 |
| Date Added to Maude | 2016-11-30 |
| 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 CARDIAC TRIPLE MARKER PANEL |
| Generic Name | CARDIAC MARKER TEST |
| Product Code | NBC |
| Date Received | 2016-11-30 |
| Model Number | 97000HSEU |
| Lot Number | W62034RB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-11-30 |