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 2017-10-27 for COBAS 8000 COBAS ISE MODULE (DOUBLE) COBAS 8000 ISE 05964075001 manufactured by Roche Diagnostics.
[91205948]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91205949]
The customer stated they were receiving "high" ise indirect potassium for gen. 2 results for patient samples on the cobas 8000 ise module. The customer provided data for 10 patient samples that were part of comparison studies performed as part of the customer's investigation into complaints by their clients. Of the ten patient samples provided, only the results for one sample were discrepant. The initial result was 4. 8 mmol/l and was reported outside of the laboratory. The repeat result was 4. 3 mmol/l. Repeat testing was performed on a different analyzer and deemed to be correct. There was no adverse event. The potassium electrode lot number and expiration date was requested but not provided. The field service engineer (fse) found the dilution nozzles were misadjusted. The fse adjusted the dilution nozzles, cleaned the ise mixing vessels, and checked the sample probe. The fse performed a precision that was within manufacturer? S specifications. The customer ran calibration and quality control with results that were within specifications.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1823260-2017-02437 |
MDR Report Key | 6983218 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2017-10-27 |
Date of Report | 2017-11-17 |
Date of Event | 2017-09-20 |
Date Mfgr Received | 2017-10-13 |
Date Added to Maude | 2017-10-27 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
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 | HITACHI HIGH TECH CORP. |
Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
Manufacturer City | IBARAKI 312-8504 |
Manufacturer Country | JA |
Manufacturer Postal Code | 312-8504 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | COBAS 8000 COBAS ISE MODULE (DOUBLE) |
Generic Name | CLINICAL CHEMISTRY ANALYZER |
Product Code | CEM |
Date Received | 2017-10-27 |
Model Number | COBAS 8000 ISE |
Catalog Number | 05964075001 |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 0 |
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 | 2017-10-27 |