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 2017-10-09 for ISE INDIRECT K+ FOR GEN.2 10825441001 manufactured by Roche Diagnostics.
[89951178]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89951179]
The customer complained of questionable patient data and questionable college of american pathologists (cap) survey results for ise indirect k for gen. 2. The customer reported that while running cap survey samples they received critical potassium values. The cap survey samples repeated automatically and the repeat values did not match the initial values. The customer decided to repeat 3 patient samples that were initially run before the cap samples. For 2 of the patients the initial potassium results did not match the repeat results. The customer tried recalibrating and running qc but received calibration alarms on potassium. The customer changed the potassium electrode the following day. After bringing the system back up to operational, the customer repeated the previously mention 2 patients samples along with 5 more patient samples. For the 2 patient samples, the newly generated potassium results matched the initial results that were obtained before the cap survey issues. The initial results were the only results reported outside of the laboratory so no corrected reports had to be issued. For the other 5 patient samples a reportable malfunction for potassium was obtained. Please refer to the attachment of this medwatch for discrepant potassium results. For all 5 patients the initial results were reported outside of the laboratory and corrected reports had to be issued. There were no adverse events. The cobas 6000 c (501) module serial number was (b)(4). The field engineering specialist (fes) could not find a cause. The customer had already replaced the potassium electrode and performed ion selective electrode (ise) checks, calibration, qc, and precision testing. The customer had continued to use the instrument after replacing the potassium electrode. The fes replaced the sipper nozzle due to precipitate build up and minor abrasion. He also performed mechanical alignments. He recalibrated and performed ise checks. The customer completed qc and repeated the prior days reported potassium results. All results were within range with no errors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02226 |
| MDR Report Key | 6928771 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-09 |
| Date of Report | 2017-10-10 |
| Date of Event | 2017-09-20 |
| Date Mfgr Received | 2017-09-20 |
| Date Added to Maude | 2017-10-09 |
| 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 | ISE INDIRECT K+ FOR GEN.2 |
| Generic Name | ELECTRODE, ION SPECIFIC, POTASSIUM |
| Product Code | CEM |
| Date Received | 2017-10-09 |
| Model Number | NA |
| Catalog Number | 10825441001 |
| Lot Number | AKSU |
| ID Number | NA |
| 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 | 2017-10-09 |