MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2017-08-29 for TRIAGE PROFILER SOB PANEL 25T 97300EU manufactured by Alere San Diego, Inc..
[83987812]
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w62754b. No issues with ckmb recovery were observed. Manufacturing batch records for the lot 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. This event is being reported as device is same/similar to 510k: k080269.
Patient Sequence No: 1, Text Type: N, H10
[83987813]
On (b)(6) 2017, a nurse tested her own edta blood sample using the triage profiler sob panel and received a normal ck-mb result of <1. 0 ng/ml. The sample was sent to the laboratory and produced an abnormal ck-mb result of 37 u/l. No treatment or intervention was administered or withheld based on the triage ck-mb result. Facility triage ck-mb normal cutoff= 4. 3ng/ml. Facility laboratory ck-mb normal cutoff= 24u/l.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00138 |
| MDR Report Key | 6828989 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-08-22 |
| Date Mfgr Received | 2017-08-22 |
| Date Added to Maude | 2017-08-29 |
| 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 25T |
| Generic Name | CARDIOPROFILER PANEL |
| Product Code | JHX |
| Date Received | 2017-08-29 |
| Model Number | 97300EU |
| Lot Number | W62754B |
| 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 | 2017-08-29 |