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 2018-05-15 for ELECTRODE CHLORIDE CL/ISE 03003523001 manufactured by Roche Diagnostics.
[108367817]
Expiration date the expiration date is provided as "install before (b)(6) 2018. " (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108367818]
The customer complained of a questionable ise indirect cl for gen 2 result for 1 patient sample tested on a cobas integra 400 plus. The initial chloride result was 82 mmol/l. The customer stated that following the initial erroneous result there were multiple analyzer alarms. The repeat chloride results were 110 mmol/l with a data flag. The customer repeated the chloride testing after a new successful calibration and got a result of 106 mmol/l. The customer stated that they did not repeat the potassium and sodium testing because the customer believed the original results were acceptable. The erroneous result was not released outside of the laboratory. The chloride result of 106 mmol/l was deemed to be correct and was reported outside of the laboratory. There was no adverse event. The integra 400+ serial number was (b)(4). On (b)(6) 2018 the customer tried calibrating the ise's multiple but the chloride calibration kept failing. The customer had to install a previous chloride electrode of the same lot to ge a successful calibration and qc results. The customer declined to have service dispatched and stated that they have not had any further issues. Further investigation determined that calibration and qc results prior to the event were acceptable. It was determined that the root cause may be related to the glue that is used to fix the membrane to the electrode housing which can cause the membranes to not be properly fixed and tight.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01505 |
| MDR Report Key | 7515033 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-15 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-05-01 |
| Date Added to Maude | 2018-05-15 |
| 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 | 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 | ELECTRODE CHLORIDE CL/ISE |
| Generic Name | ELECTRODE, ION-SPECIFIC, CHLORIDE |
| Product Code | CGZ |
| Date Received | 2018-05-15 |
| Model Number | NA |
| Catalog Number | 03003523001 |
| Lot Number | 21574847 |
| ID Number | NA |
| Device Expiration Date | 2018-05-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-05-15 |