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 2018-08-10 for ELECTRODE CHLORIDE CL/ISE 03003523001 manufactured by Roche Diagnostics.
[117161092]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[117161093]
The customer complained of high results for multiple patients tested for chloride (cl) on two cobas integra 400 plus instruments with serial numbers (b)(4). The customer provided data for 11 patient samples tested on the integra 400 plus instruments compared to a cobas 8000 ise module. Based on the data provided, the results for 3 patient samples were discrepant. It is not clear if this data was generated for diagnostic purposes or if it was generated for troubleshooting only. Clarification on this was requested but not provided. Patient 1 initial cl result on an integra 400 plus instrument was 103 mmol/l. The repeat result from the ise module was 103 mmol/l. Patient 2 initial cl result on an integra 400 plus instrument was 112 mmol/l. The repeat result from the ise module was 101 mmol/l. Patient 3 initial cl result on an integra 400 plus instrument was 113 mmol/l. The repeat result from the ise module was 102 mmol/l. It is not clear which integra 400 plus instrument serial number was used for the initial tests. Both instruments used the same cl electrode lot number. No erroneous results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The customer said there were no problems with qc; however, the results provided appeared to be too high. The customer noticed calibration variations on both instruments for cl. There were no issues with sodium or potassium. An ise check was performed on both instruments. Based on these results, maintenance was performed along with an additional ise check. The reference cartridge for integra 400 plus serial number (b)(4) was changed as it had been installed in 2017. Pipes and towers had been replaced in (b)(6) 2018. After replacing the reference cartridge, the customer got the high cl results on integra 400 plus serial number (b)(4). Based on this, the customer decided to change the cl electrode on both instruments to lot number 2158847. After the new cl electrode was installed, qc results were better and calibrations were more stable for integra 400 plus serial number (b)(4). Calibration variations were still noticed on integra 400 plus serial number (b)(4). The field service engineer (fse) visited the customer site and performed preventive maintenance on integra 400 plus serial number (b)(4). The customer performed a 2nd comparison between the integra 400 plus instruments and the cobas 8000 ise module. The results compared well to one another. The fse revisited the customer site on 24-jul-2018 to check the customer's water quality. The root cause of the issue was the cl electrode and the glue used to attach the membrane to the electrode housing. The glue caused the membrane to not be properly fixed to the electrode. When the customer replaced the cl electrode, the results were within specification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02675 |
| MDR Report Key | 7772495 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-10 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-07-17 |
| Date Mfgr Received | 2018-07-18 |
| Date Added to Maude | 2018-08-10 |
| 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 | ELECTRODE CHLORIDE CL/ISE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-08-10 |
| Model Number | NA |
| Catalog Number | 03003523001 |
| Lot Number | 21581447 |
| 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 | 2018-08-10 |