MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-12 for ISE 9180 03157334001 manufactured by Roche Diagnostics.
[3863819]
The customer received questionable ion selective electrode (ise) lithium results for three patient samples. Data was only provided for one patient sample. The initial result was 1. 41 meq/l and was reported outside the laboratory. They called the nurses to stop them from treating the patient and sent the sample out to another lab to be tested. The customer believed the other laboratory also used a roche 9180 analyzer. The repeat result was 0. 66 meq/l and was used to treat the patient. The patient was not adversely affected. The lithium electrode lot number was 21524641 with an expiration date of 05/31/2013. It was noted the customer had installed the lithium electrode on (b)(4) 2013 which was after the recommended date for use. The customer was advised to replace the electrodes.
Patient Sequence No: 1, Text Type: D, B5
[11089038]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11195243]
The customer replaced the electrodes and stated the issue was resolved.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-05648 |
| MDR Report Key | 3345789 |
| Report Source | 05,06 |
| Date Received | 2013-09-12 |
| Date of Report | 2013-09-17 |
| Date of Event | 2013-07-30 |
| Date Mfgr Received | 2013-08-27 |
| Date Added to Maude | 2013-09-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | KRATKYSTRASSE 2 NA |
| Manufacturer City | GRAZ A8020 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | A8020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISE 9180 |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JFP |
| Date Received | 2013-09-12 |
| Model Number | NA |
| Catalog Number | 03157334001 |
| Lot Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-12 |