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 2017-04-13 for TRIAGE CARDIAC TRIPLE MARKER PANEL 97000HS manufactured by Alere San Diego, Inc..
[72808712]
Investigation conclusion: it is indicated that the product is not returning for evaluation. As the customer was unable to provide a lot number, a manufacturing record review and testing on reserve sample from the same lot could not be performed. Further investigation is not possible at this time. 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
[72808713]
The customer reported receiving a triage ck-mb result= "2 point something" ng/ml as compared to a laboratory ck-mb result of 9. 3 ng/ml on one patient. The clinical presentation of the patient and information regarding possible treatment was not provided. Although requested, no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00067 |
| MDR Report Key | 6492401 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-04-13 |
| Date of Report | 2017-03-14 |
| Date Mfgr Received | 2017-03-14 |
| Date Added to Maude | 2017-04-13 |
| 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 | JHX |
| Date Received | 2017-04-13 |
| Model Number | 97000HS |
| Lot Number | UNKNOWN |
| 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 | 2017-04-13 |