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 2017-01-04 for TRIAGE TOTAL 5 CONTROL L1 88753 manufactured by .
[63884748]
Mdr is being filed due to field action ref-2027969-10/12/16-004-c. 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, (b)(4), was initiated to address this issue. Date of this report selected as 9/29/2016 to reflect the date in which field corrective action 2027969-10/12/16-004-c was initiated.
Patient Sequence No: 1, Text Type: N, H10
[63884749]
The customer attempted to run the total 5 control level 1 at 2 stdev with a d-dimer result outside of the expected range low at 386 ng/ml (2 stdev: 390-584 ng/ml). The customer repeated the test with the total 5 control level 1 at 1 stdev. The d-dimer result was outside of the expected range low at 401 ng/ml (1 stdev: 438-536 ng/ml). The customer also reported a low bias and results outside of expected ranges for multiple total 5 controls and calibrators. A later retest using an alternate lot of total 5 controls produced results within the expected range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00007 |
| MDR Report Key | 6223482 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-01-04 |
| Date of Report | 2016-09-29 |
| Date Mfgr Received | 2016-12-14 |
| Date Added to Maude | 2017-01-04 |
| 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 | 2017-01-04 |
| Model Number | 88753 |
| Lot Number | C3233A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-04 |