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 2019-05-17 for ROCHE 9180 ELECTROLYTE ANALYZER ISE 9180 03157334001 manufactured by Roche Diagnostics.
[145425331]
This event occurred in (b)(6). The field service engineer (fse) visited the customer site and inspected the instrument: removed the tubing harness, electrodes, needle and wash port. The instrument surfaces were thoroughly cleaned. The fse noted evidence of leakage as crystals were observed underneath the chassis. The crystal buildup was cleaned up from the external surfaces. The main board was removed and the back of valves were inspected. Evidence of leakage was observed and some valves were rusty. The fse cleaned the internal crystal buildup and replaced the vent and valve line. Preventive maintenance was performed. The instrument initially calibrated for sodium and chloride but k+ failed. The fse performed additional cleaning cycles and k+ calibrated ok afterwards. Three levels of qc were acceptable. The fse ran qc again and k+ was out of range high for level 3. The instrument was calibrated again and qc was acceptable. The instrument was put back in service with a new electrode. The customer has not had any further issues since the service visit.
Patient Sequence No: 1, Text Type: N, H10
[145425332]
The initial reporter complained of discrepant results for 1 patient sample tested for potassium (k+) on an electrolyte analyzer ise 9180 instrument compared to an abl 90 flex instrument. The result from the ise 9180 instrument was 3. 5 mmol/l. The same sample was run on an abl 90 flex instrument and the result was 5. 2 mmol/l. There was no allegation that an adverse event occurred. The k+ electrode lot number was 21584549. The expiration date was not provided. The customer stated qc had been performed daily and had passed. After this event, qc was run and the results were low for k+. The customer changed the fluid pack and qc was back within the acceptable range. After making this change, the customer compared 2 patient samples from the ise 9180 to the abl 90 flex instrument and the results were comparable to one another. On (b)(6) 2019 the customer had issues with qc results for k+ not passing again and the k+ parameter could not be calibrated at all.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01869 |
| MDR Report Key | 8620976 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-17 |
| Date of Report | 2019-07-16 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2019-04-30 |
| Date Added to Maude | 2019-05-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ROCHE 9180 ELECTROLYTE ANALYZER |
| Generic Name | ELECTROLYTE ANALYZER |
| Product Code | JFP |
| Date Received | 2019-05-17 |
| Model Number | ISE 9180 |
| Catalog Number | 03157334001 |
| Lot 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 | 2019-05-17 |