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 2017-02-16 for ISE 9180 03157334001 manufactured by Roche Diagnostics.
[67814799]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[67814800]
The customer received questionable ise indirect na, k, ci for gen. 2 sodium results for an unknown number of patient samples. Specific data was requested but was not provided. Information concerning if any erroneous result was reported outside the laboratory was requested, but it was unknown. There was no adverse event. The electrode lot number and expiration date were requested but were not provided.
Patient Sequence No: 1, Text Type: D, B5
[67852523]
Additional information was provided that the erroneous results were not reported outside the laboratory. The electrode was cleaned and qc was performed which was in range.
Patient Sequence No: 1, Text Type: N, H10
[71845232]
Information was provided that the sodium result from the roche analyzer was "130 mmol" and the result from another laboratory was "138 mmol". The sodium electrode lot number was 21562347. Result printouts could not be provided nor the na electrode that was used in the alleged measurements. No further information or data was available for this complaint. Trending on the lot number of the na electrode showed no other complaints. The certificate of analysis of this electrode batch showed no indication for the complained issue. Based on the information provided, no issue could be found with the analyzer. The customer was using biorad qc material which is not approved for use on this analyzer. Product labeling states that the use of consumables that were not produced by roche, including but not limited to electrodes, calibration and cleaning solutions, qc-material, and related accessories may result in malfunction of the analyzer and may lead to incorrect patient results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00351 |
| MDR Report Key | 6336174 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-16 |
| Date of Report | 2017-03-21 |
| Date of Event | 2017-01-23 |
| Date Mfgr Received | 2017-01-23 |
| Date Added to Maude | 2017-02-16 |
| 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 | 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 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 | 2017-02-16 |
| Model Number | ISE 9180 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-16 |