MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-10-18 for TRIAGE TOTAL 5 CONTROL L1 88753 manufactured by .
[57804984]
Mdr is being filed due to field action (b)(4). Customer's complaint was replicated with in-house testing of the code chip of retain lot c3233a. Code chip ranges did not match ev card ranges. The manufacturing records for the control lot were reviewed and the lot met release specifications. A capa, capa-(b)(4), was initiated to address this issue.
Patient Sequence No: 1, Text Type: N, H10
[57805025]
The support consultant attempted to run the total 5 control level 1 twice at 2 stdev with myoglobin results outside of the expected range high at 132 ng/ml and 131 ng/ml (2 stdev: 71. 9-119 ng/ml). The support consultant installed a code chip from a different box of controls with the same lot number and then attempted to run the total 5 control level 1 at 3 stdev with a myoglobin result outside of the expected range high at 124 ng/ml (3 stdev: 60. 2-131 ng/ml).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2016-00653 |
| MDR Report Key | 6038570 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-10-18 |
| Date of Report | 2016-09-29 |
| Date of Event | 2016-09-09 |
| Date Mfgr Received | 2016-09-29 |
| Date Added to Maude | 2016-10-18 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | 2027969-10/12/16-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE TOTAL 5 CONTROL L1 |
| Generic Name | MULTI-ANALYTE CONTROLS |
| Product Code | JJY |
| Date Received | 2016-10-18 |
| Returned To Mfg | 2016-10-11 |
| Model Number | 88753 |
| Lot Number | C3233A |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-18 |