MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-06-04 for ISE 9180 03107019001 manufactured by Roche Diagnostics.
[11975816]
Manufacturing site name was updated.
Patient Sequence No: 1, Text Type: N, H10
[12231608]
A definitive root cause could not be determined. It noted the customer did not run quality control prior to testing the samples. It was noted the sodium and potassium had been on board the analyzer for over a year and were passed their on board times. Quality control verification by the customer should have informed them of the state of the electrodes.
Patient Sequence No: 1, Text Type: N, H10
[16818205]
The customer provided data for three patients with questionable ion selective electrode potassium results, of which two had discrepant results that were reported outside the laboratory. The samples were tested on (b)(6) 2014. The samples were repeated on another 9180 analyzer. The first patient's initial potassium result was 7. 35 mmol/l. The repeat result was 8. 2 mmol/l. The second patient's initial potassium result was 4. 5 mmol/l. The repeat result was 5. 0 mmol/l. Information on whether the patients were adversely affected was requested but not provided. The potassium electrode lot number was 21522761. The expiration date was requested but not provided.
Patient Sequence No: 1, Text Type: N, H10
[18296958]
The customer alleged they received very low ion selective electrode sodium and potassium results on their ise 9180 analyzer. The customer provided data for one discrepant sodium result that was reported outside the laboratory. The patient's initial sodium result was 95 mmol/l. The repeat result was 109 mmol/l. The patient was not adversely affected by this event. The sodium electrode lot number was requested but not provided. The field service representative checked and cleaned the electrodes, needle, and wash port. He tested the electrodes and found variations. He performed calibration. He ran samples and found variations in the sodium and potassium results. It was noted the customer was not performing quality control on the analyzer to check the performance of the system.
Patient Sequence No: 1, Text Type: D, B5
[18538958]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[21569152]
Additional information has been provided. The sodium electrode lot number was 21522955.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-04013 |
| MDR Report Key | 3849117 |
| Report Source | 01,05,06 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-08-08 |
| Date of Event | 2014-05-20 |
| Date Mfgr Received | 2014-05-20 |
| Date Added to Maude | 2014-06-04 |
| 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 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 INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| 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 | 2014-06-04 |
| Model Number | NA |
| Catalog Number | 03107019001 |
| 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 | 2014-06-04 |