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 2019-03-29 for ISE CALIBRATOR INDIRECT/URINE 20763063122 manufactured by Roche Diagnostics.
[140296031]
Patient Sequence No: 1, Text Type: N, H10
[140296032]
The initial reporter stated that she ran calibration and controls on the cobas integra 400 plus in the morning. The reporter stated that she then received an alarm indicating that the na+ electrode and the k+ electrode needed to be changed. The reporter changed the electrodes and then ran an unspecified number of patient samples. She stated that the ise results for these samples did not look right. The reporter then successfully re-calibrated the ise tests and acceptable control results were generated. The samples were repeated. Of the samples that were repeated, five had erroneous initial results that were reported outside of the laboratory for the chloride electrode. The repeat results were believed to be correct. The first sample initially resulted with a chloride value of 125 mmol/l, which repeated as 99 mmol/l. The second sample initially resulted with a chloride value of 123 mmol/l, which repeated as 102 mmol/l. The third sample initially resulted with a chloride value of 122 mmol/l, which repeated as 108 mmol/l. The fourth sample initially resulted with a chloride value of 120 mmol/l, which repeated as 107 mmol/l. The fifth sample initially resulted with a chloride value of 120 mmol/l, which repeated as 106 mmol/l. No adverse events were alleged to have occurred with the patients. The field service engineer determined the issue was caused by the on board ise calibrator indirect solution. He replaced the calibrator solution. The operator ran calibration and controls. Calibration, controls, and patient samples were within range and stable. All analyzer checks passed. Calibration data showed alarms indicating an unstable ise. The investigation determined that the issue was resolved by the service actions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01254 |
| MDR Report Key | 8463730 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-03-12 |
| Date Added to Maude | 2019-03-29 |
| 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 DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISE CALIBRATOR INDIRECT/URINE |
| Generic Name | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| Product Code | JIX |
| Date Received | 2019-03-29 |
| Model Number | ISE CALIBRATOR INDIRECT |
| Catalog Number | 20763063122 |
| Lot Number | 3631270 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-03-29 |