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 2016-09-15 for COBAS B 121 manufactured by Roche Diagnostics.
[54893212]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[54893213]
The customer questioned thb results for 1 patient tested on the roche omni s cobas b 221 system and the cobas b 121 system. Although the cobas b 121 system is not sold in the united states, the measuring principal for thb on the cobas b 121 system is similar to the measuring principal for thb on the cobas b 221 system. Based on the data provided, erroneous thb and hct results were identified. This medwatch will cover the b 121 system. Refer to medwatch with patient identifier (b)(6) for information on the b 221 system. On (b)(6) 2016 the thb result from the cobas b 121 system was 6. 5 g/dl. The result from the customer's sysmex system was 8. 6 g/dl. The hct result from the cobas b 121 system was 16. 5%. The result from the customer's sysmex system was 23. 2%. On (b)(6) 2016 the hct result from the cobas b 221 system was 16. 2%. The result from the customer's sysmex system was 21. 3%. On (b)(6) 2016 the thb result from the cobas b 221 system was 6. 3 g/dl. The result from the customer's sysmex system was 9. 1 g/dl. The hct result from the cobas b 221 system was 14. 6%. The result from the customer's sysmex system was 24. 6%. No adverse event occurred. It was noted that quality controls (qc) were acceptable on both the cobas b 221 system and the cobas b 121 system. The last time preventive maintenance was performed on the b 221 system was in june, 2016. Lithium heparin syringes were used for the cobas b 221 and cobas b 121 system results. Edta syringes were used for the sysmex results. It is not clear if the lithium heparin syringes used for the cobas b 221 and cobas b 121 were drawn at the same time as the edta syringes used for the sysmex system. This information was requested. The investigation noted that both the cobas b 221 system and the cobas b 121 system use different measuring technologies than the sysmex system which could lead to different results between the systems. Another potential root cause for the difference in results may be related to a pre-analytic issue such as sedimentation of the sample.
Patient Sequence No: 1, Text Type: D, B5
[55702420]
It was clarified that the lithium heparin syringes used for the cobas b 221 and cobas b 121 were drawn at the same time as the edta syringes for the sysmex.
Patient Sequence No: 1, Text Type: N, H10
[58855885]
A specific root cause could not be identified. Additional information was requested for investigation but was not provided. The investigation noted that the mchc (mean corpuscular hemoglobin concentration) results on (b)(6) 2016, (b)(6) 2016 and (b)(6) 2016 were quite high and probably not related to the condition of the patient. The mchc is the quotient of thb/hct and uses a unit of measure of g/dl. The detection method for thb is different. The high mchc values are probably caused by the same issue that caused the discrepant thb results when compared to the sysmex results. The most common cause of such an issue is the use of an in-homogeneous sample. Sedimentation of erythrocytes can occur in the container if the sample is not measured immediately. If the sample is not measured immediately, the container should be rolled prior to measurement. Based on the information available for investigation, a pre-analytic issue is the most likely root cause of the erroneous results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01384 |
| MDR Report Key | 5953351 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-15 |
| Date of Report | 2018-04-04 |
| Date of Event | 2016-08-14 |
| Date Mfgr Received | 2016-08-25 |
| Date Added to Maude | 2016-09-15 |
| 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 |
| 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 | COBAS B 121 |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2016-09-15 |
| Model Number | NA |
| Catalog Number | ASKU |
| 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 | 2016-09-15 |