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 2016-09-22 for CALCIUM GEN. 2 05061482190 manufactured by Roche Diagnostics.
[55448502]
Na.
Patient Sequence No: 1, Text Type: N, H10
[55448503]
The customer experienced an issue with ca2 calcium gen. 2 on cobas c501 serial number (b)(4). The qc results were out of range high so they repeated the qc and it was still out of range high. The customer replaced the reagent and the qc was out of range low. The customer recalibrated the assay and the qc was then within the acceptable range. The customer then tested patient samples, but received a call from one physician's office complaining of lower than normal results. The customer repeated about 20 samples on another analyzer and the results increased "about 2 points". Of the data provided for 25 patient samples, the results for 20 patient samples were discrepant. Refer to the attachment to the medwatch for all patient data. The erroneous results were reported outside the laboratory. The repeat results were believed to be correct. The patients were not adversely affected. To resolve the issue, the customer said they ran qc and it was out of range low. They recalibrated the assay and it was "fine". As they had passing qc results, they began reporting patient results again. After looking at the calibration trace, the customer suspected the issue was possibly caused by a bad calibration. The field service representative could not find a cause. He observed the last calibration and qc had passed for calcium. He performed mechanism checks, verified proper rinse volumes and the gear pump pressure was within specifications. He performed instrument precision and accuracy checks which were all within specification. Further investigation found unstable standard values for the calibration results 09/08/2016. This could possibly indicate a contamination issue with the standard or a water quality issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-01442 |
| MDR Report Key | 5970569 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-22 |
| Date of Report | 2016-09-22 |
| Date of Event | 2016-09-08 |
| Date Mfgr Received | 2016-09-09 |
| Date Added to Maude | 2016-09-22 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | CALCIUM GEN. 2 |
| Generic Name | TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM |
| Product Code | CHW |
| Date Received | 2016-09-22 |
| Model Number | NA |
| Catalog Number | 05061482190 |
| Lot Number | 161565 |
| ID Number | NA |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-09-22 |