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 2017-06-09 for COBAS INTEGRA 400 PLUS I400+ 03245233692 manufactured by Roche Diagnostics.
[77446559]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77446560]
The customer received questionable high ise indirect for gen. 2 chloride results for multiple samples over two days. He changed the electrode, the calibrator solution, the reference electrode, and the mix tower but the results were still high. The customer sent samples to another laboratory for testing. Of the data provided for four patient samples, only the results for one patient were discrepant. The initial chloride result was 106 mmol/l and the repeat result was 96 mmol/l. The initial result was reported outside the laboratory. The repeat result was believed to be correct. The patient was not adversely affected. The electrode lot number and expiration date were requested but were not provided. The field service representative found a problem with the vacuum/ pressure and the mix /dry line from the pump was kinked and restricting flow. He replaced the tubing to the air pump, rerouted the lines, and wrapped them in place. He performed mix/dry adjustments to specification and the customer successfully ran calibration and controls with results near the mean values.
Patient Sequence No: 1, Text Type: D, B5
[117969145]
Clarification was provided that the customer runs the ise direct method. Based on this, an incorrect mixing pressure as found by the field service representative would not have cause the event. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Possible causes include an issue with the sample itself or a preanalytical problem. No information was provided that reasonably suggests a systemic problem with the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01184 |
| MDR Report Key | 6629159 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-09 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-05-24 |
| Date Mfgr Received | 2017-05-24 |
| Date Added to Maude | 2017-06-09 |
| 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 | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | COBAS INTEGRA 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CGZ |
| Date Received | 2017-06-09 |
| Model Number | I400+ |
| Catalog Number | 03245233692 |
| 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 |
| Brand Name | COBAS INTEGRA 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-09 |
| Model Number | I400+ |
| Catalog Number | 03245233692 |
| 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 | 2017-06-09 |