MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-03-15 for ISE INDIRECT NA, K, CI FOR GEN.2 03246353001 manufactured by Roche Diagnostics.
[70079649]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70079650]
The customer stated that they calibrated their ise indirect ci for gen. 2 (chloride) test on the cobas 6000 c (501) module - c501 on the morning of (b)(6) 2017. They received no alarms on the calibration and the controls recovered correctly. The customer then stated that they ran an unspecified number of patient samples and all the results were 102. 9 mmol/l. At noon on the same day it was not possible to run controls on chloride, although controls for other ise tests were ok. The customer then performed a calibration. The calibration and control recovery passed. The patient samples were repeated and the results were different. There were 14 patient samples that had the initial results of 102. 9 mmol/l starting at 9:06 a. M.. Of these 14 samples, 2 had erroneous results. It was asked, but it is not known if any erroneous results were reported outside of the laboratory. The first sample initially resulted as 102. 9 mmol/l and repeated as 88. 9 mmol/l. The second sample initially resulted as 102. 9 mmol/l and repeated as 87. 1 mmol/l. The patients were not adversely affected. The serial number of the c501 analyzer was (b)(4). On (b)(6) 2017 the chloride electrode was replaced. The issue was most likely related to contamination of the electrode. A review of calibration data showed a response time factor associated with almost every calibration performed in (b)(6). Response time increases when contamination is present.
Patient Sequence No: 1, Text Type: D, B5
[73581841]
Based upon investigations, the results of 102. 9 mmol/l can be considered to be correct as 12 of the 14 samples showed a consistent repeat result. The repeat results of 88. 9 mmol/l and 87. 1 mmol/l are caused by a deteriorated electrode due to contamination. Electrode contamination can be caused by pre-analytic sample handling issues. Investigations also determined that there were no issues with the analyzer software.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00561 |
| MDR Report Key | 6405522 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-15 |
| Date of Report | 2017-04-24 |
| Date of Event | 2017-02-27 |
| Date Mfgr Received | 2017-02-27 |
| Date Added to Maude | 2017-03-15 |
| 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 | 2017-03-15 |
| Model Number | NA |
| Catalog Number | 03246353001 |
| Lot Number | B65 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-03-15 |