MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-01-19 for KIT, TRIAGE, CARDIAC TNI 97021HS manufactured by Alere San Diego, Inc..
[65360562]
Investigation conclusion: customer's complaint was not replicated with in-house testing of retain lot w61754. No issues with tni recovery were observed. Manufacturing batch records for lot w61754 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.
Patient Sequence No: 1, Text Type: N, H10
[65360563]
Notification received of a troponin discrepancy. On (b)(6) 2016 (b)(6) male presented to hospital with chest pain, shortness of breath and cough. Admitting diagnosis: mi, chf and elevated wbc. Discharge diagnosis: pneumonia, discharged to care center on (b)(6) 2016. Report received of discrepancy between the triage meter vs. Beckman unicel vs. Roche at (b)(6). Triage meter result, <0. 05 on (b)(6), 11:03 a. M. ; range (0. 0-0. 4). Beckman unicel result, 0. 13 on (b)(6); range (0. 0-0. 03); plasma lithium heparin sample caller stated the with beckman <0. 01 is negative result; >0. 49, positive for mi; range 0-85. Both of the samples were drawn on (b)(6) 2016; 5:28 a. M. ; rainbow collection. Edta tube spun to plasma immediately prior to testing on the triage meter. Roche sample was tested at (b)(6), result 0. 10 on (b)(6) at 1700; range (0. 0-0. 12).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00019 |
| MDR Report Key | 6264517 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-01-19 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-12-07 |
| Date Mfgr Received | 2016-12-22 |
| Date Added to Maude | 2017-01-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | KIT, TRIAGE, CARDIAC TNI |
| Generic Name | CARDIAC MARKER TEST |
| Product Code | NBC |
| Date Received | 2017-01-19 |
| Model Number | 97021HS |
| Lot Number | W61754RB |
| 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 | 2017-01-19 |