MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-12-28 for CALIBRATOR FOR AUTOMATED SYSTEMS USA STANDARDIZED 10759350360 manufactured by Roche Diagnostics.
[96235755]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[96235756]
The customer complained that for ca calcium their running averages for both qc and patient samples have been showing a drift. The customer provided the calcium results for 8 patient samples that were tested on 4 different analytical p module (modp) analyzers. Of the data provided, 1 patient result was a reportable malfunction. The initial calcium result was 7. 6 mg/dl. The sample was tested at an outside laboratory and a calcium result of 9. 2 mg/dl was obtained. The erroneous result was reported outside of the laboratory. There was no adverse event. The result from the outside laboratory was deemed to be correct. The customer mentioned qc and patient results for calcium have been showing this drift over the last few months for all 4 of their modps. The customer did not know which specific modp the above mentioned patient result was generated on. The customer stated that there has been 4 different lots of reagent used over the last few months. The 4 serial numbers for the modps are sn (b)(4). The customer stated that most samples were processed by modular pre-analytics system, but the customer did not know for sure if some samples may have been tested directly from the sample tube. The field engineering specialist found that calibrator for automated systems (c. F. A. S. ) lot 19883101 was the cause of the issue. He replaced the c. F. A. S. With a new lot, 26907201, and this resolved the issue resulting in qc and patient recovery shifting up. He verified system operation by performing calibration and qc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-03137 |
| MDR Report Key | 7150813 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-28 |
| Date of Report | 2018-03-05 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2017-12-15 |
| Date Added to Maude | 2017-12-28 |
| 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 | 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 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALIBRATOR FOR AUTOMATED SYSTEMS USA STANDARDIZED |
| Generic Name | CALIBRATOR |
| Product Code | JIX |
| Date Received | 2017-12-28 |
| Model Number | NA |
| Catalog Number | 10759350360 |
| Lot Number | 19883101 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-28 |