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 2017-04-19 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[73184015]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73184016]
The customer stated that they received questionable results for three patient samples tested for glucose (glu) and lactate (lac) on a cobas b 221<6>=roche omni s6 system (b221). Of the three samples, two had erroneous glucose and lactate results that were reported outside of the laboratory. The first patient sample initially resulted as 0. 8 mmol/l accompanied by a data flag for glu and < 0. 6 mmol/l accompanied by a data flag for lac. The sample was repeated on a different b221 analyzer, resulting as 6. 9 mmol/l accompanied by a data flag for glu and 2. 0 mmol/l accompanied by a data flag for lac. The sample was also repeated on an accu-chek inform ii meter, resulting with a glu value of 6. 8 mmol/l. All measurements on the complained b221 analyzer were performed with sensor lot number 21564748 installed on (b)(6) 2017. In order to resolve the issue, the customer then changed the sensor on (b)(6) 2017 with new sensor lot 21570247. A second patient sample was tested on the complained b221 analyzer, the second b221 analyzer, and the accu-chek inform ii meter. No erroneous results were generated from this sample. The laboratory asked the staff to keep an eye on results. On (b)(6) 2017, a third patient sample was tested on the complained b221 analyzer, resulting as 0. 7 mmol/l accompanied by a data flag for glu. The sample was tested on the accu-chek inform ii meter, resulting as 13. 9 mmol/l. No adverse events were alleged to have occurred with the patients. The field service engineer performed a deep cleaning of the sensor pathway. After this action, further glu measurements have not been questioned by the customer.
Patient Sequence No: 1, Text Type: D, B5
[74181866]
Upon review of analyzer log information, no bacterial contamination was present at the time of the alleged measurements.
Patient Sequence No: 1, Text Type: N, H10
[77945042]
A specific root cause could not be determined based on the provided information. The reported discrepancy for the first and third patient samples could be confirmed. Optical inspection of the sensor did not reveal any indications for a malfunction of the device or the sensor itself. Major fluidic problems and bacterial contamination can be excluded as the source of the erroneous glucose results. Based on the provided data, no malfunction of the device could be identified. It was not possible to exclude the presence of micro air bubbles caused by minor leakages in the fluid path of the system. Some of the medications taken, such as paracetamol and ascorbic acid, are known to influence the measurement result to a certain degree. Based on typical concentrations in the blood sample, the effect of these interferences on the glucose result would be expected to be significantly lower than in the case of the reported measurements. Immediate measurement on a different b221 device resulted in a concentration comparable to the results obtained with the inform ii device. This indicates there was no systematic interference on the glucose sensor. The production record of the device showed no indication of the alleged issue. The certificate of analysis for the sensor did not show an issue. Complaint trending of the sensor that was used showed no similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[132589590]
Medwatch has been updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00816 |
| MDR Report Key | 6503388 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-19 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-03-24 |
| Date Mfgr Received | 2017-03-27 |
| Date Added to Maude | 2017-04-19 |
| 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 | ROCHE OMNI S |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2017-04-19 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| 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 | 2017-04-19 |