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 2018-09-12 for ISE INDIRECT NA, K, CI FOR GEN.2 03246353001 manufactured by Roche Diagnostics.
[119932347]
Na.
Patient Sequence No: 1, Text Type: N, H10
[119932348]
The customer initially complained about third party qc results for chloride (cl) after changing the electrode on a cobas 6000 c (501) module. Cl electrode lot # v0204 had been installed on (b)(6) 2018 and the customer had no qc issues with this electrode. On (b)(6) 2018 new cl electrode with lot # w9817 was installed. The reference electrode had last been replaced in (b)(6) 2018. Upon replacing the cl electrode, qc results shifted high. On (b)(6) 2018 the customer also questioned results for patients tested for cl. An ise check passed on the day of the event. When the ise's were calibrated, a calibration flag was generated for cl and the value was [-] 10. The tech didn't realize this and ran patient samples. Once the cl results began to show flags for delta checks, the tech stopped running patient samples. The tech re-calibrated and repeated patient samples. The customer provided data for 1 patient sample and the cl results were discrepant. The original cl result was 98 mmol/l. The repeat result was 97. 6 mmol/l. After the tech re-calibrated the cl result was 109 mmol/l. The original result had been reported outside of the laboratory. The repeat results after re-calibration were believed to be correct. No adverse event occurred. The c501 module serial number was (b)(4). The customer received new third party qc material the week of (b)(6) 2018 but they continue to have issues. The roche qc material produced results within the acceptable range. The field service engineer (fse) visited the customer site and checked to make sure the electrodes were seated correctly. O-rings were checked. Ise checks x15 were run and all results were acceptable. The customer ran qc and all results were acceptable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03108 |
| MDR Report Key | 7868054 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-12 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-08-24 |
| Date Added to Maude | 2018-09-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ISE INDIRECT NA, K, CI FOR GEN.2 |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-09-12 |
| Model Number | NA |
| Catalog Number | 03246353001 |
| Lot Number | W9817 |
| 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 | 2018-09-12 |