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 2019-04-10 for COBAS B 221 SENSOR GLU/LAC/UREA 03261085184 manufactured by Roche Diagnostics.
[141482467]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[141482468]
The initial reporter stated that they have been having ongoing issues with the glucose and lactate tests when testing patient samples using the cobas b 221 sensor glu/lac/urea on a cobas b 221 analyzer. The control performance is erratic and there is lack of result reproducibility. The field service engineer has performed extensive troubleshooting with the analyzer in order to address the issue. The customer provided data for one patient with erroneous lactate test results. The erroneous results were reported outside of the laboratory. A sample from the patient resulted with a lactate value of 4. 8 mmol/l. One hour later, a sample from this patient resulted with a lactate value of 5. 6 mmol/l. Two hours later, a sample from this patient resulted with a lactate value of 1. 6 mmol/l. The results did not fit the clinical picture of the patient as the patient was believe to still be acidotic. No adverse events were alleged to have occurred with the patient. The serial number of the cobas b 221 analyzer is (b)(4). The field service engineer moved the system to a different location and updated communication settings on the system. He replaced an electrode, the cobas b 221 sensor glu/lac/urea, a system reagent, and tubing as a precaution. He ran calibration and there were issues with the calibration. He then ran wetting maintenance routines and repeated calibration. The calibration was ok. The customer ran controls and one level was outside of range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01415 |
| MDR Report Key | 8499992 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-10 |
| Date of Report | 2019-10-16 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-03-20 |
| Date Added to Maude | 2019-04-10 |
| 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 | COBAS B 221 SENSOR GLU/LAC/UREA |
| Generic Name | ACID, LACTIC, ENZYMATIC METHOD |
| Product Code | KHP |
| Date Received | 2019-04-10 |
| Model Number | NA |
| Catalog Number | 03261085184 |
| Lot Number | 21590148 |
| Device Expiration Date | 2019-04-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-04-10 |