MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-06-08 for TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM 20763454122 manufactured by Roche Diagnostics.
[5901002]
The customer reported that they received questionable results for a total of ten patient samples tested for tina-quant soluble transferrin receptor (stfr). Of the ten samples, nine were found to have erroneous results that were reported outside of the laboratory. The customer initially received a data alarm with one patient sample result. The reaction curve for the result was noted to be "jumpy" and not normal. All other results from that same day were then checked and 9 additional samples were noted to have "jumpy" reaction curves. These 9 sample results were not accompanied by alarms. The samples were repeated and results were different. The first results were reported outside of the laboratory. After noticing the issue, the laboratory communicated that there were faulty results and the repeat results were then reported outside of the laboratory. The reaction curves of other analytes appeared to be ok and these were not retested. Control results were stated to be ok on the morning of (b)(6) 2015. After the first patient results were generated, one control level was analyzed and found to be out of range. All controls were then analyzed approximately 3 hours later and all were within range. The patients were not adversely affected. The stfr reagent lot number was 606449. The reagent expiration date was asked for, but not provided. It was determined that the last calibration of the assay was performed on 05/13/2015. According to product labeling, calibration must be performed every 6 days.
Patient Sequence No: 1, Text Type: D, B5
[13347652]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[13371035]
Investigations have determined that there is an imprecision with reagent lot 606449. Retention testing of the lot has shown that precision is outside of specifications. The root cause of the reagent lot imprecision is not known. The reagent lot was changed at the customer site and no further issues were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03592 |
| MDR Report Key | 4825172 |
| Report Source | 01,05,06 |
| Date Received | 2015-06-08 |
| Date of Report | 2015-06-17 |
| Date of Event | 2015-05-20 |
| Date Mfgr Received | 2015-05-25 |
| Date Added to Maude | 2015-06-08 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM |
| Generic Name | TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL |
| Product Code | DDG |
| Date Received | 2015-06-08 |
| Model Number | NA |
| Catalog Number | 20763454122 |
| Lot Number | 606449 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-08 |