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 2017-05-22 for COBAS 8000 C 502 MODULE C502 05964067001 manufactured by Roche Diagnostics.
[75739724]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75739725]
The customer complained of erroneous results for 1 patient tested for igm-2 tina-quant igm gen. 2 (igm-2) on a cobas 8000 c 502 module. Two sample tubes were obtained for the patient on (b)(6) 2017. The igm-2 result from tube #1 was 35 mg/dl. The igm-2 result from tube #2 was 7 mg/dl. Both results were reported outside of the laboratory where the results were questioned by the doctor. On (b)(6) 2017, both sample tubes were repeated twice. The results from tube #1 were 6 mg/dl and 7 mg/dl. The results from tube #2 were 8 mg/dl and 7 mg/dl. The customer had no issues with quality controls (qc) at this time. On (b)(6) 2017, the customer stated qc was erroneous between 8:30? 9:00 p. M. A result of 102 mg/dl was received when the result should have been approximately 60 mg/dl. The customer stated the reagent pack in use at the time had about 5 tests left and was replaced with a new pack. There were no issues with the new reagent pack. The customer does not exclude sample quality issues as a possible root cause. The customer is not aware of any adverse event. The igm-2 reagent lot number was 19643001 with an expiration date of 08/31/2018. The field service engineer (fse) visited the customer site and did not identify any issues. The fse verified the internal and external rinses of the sample probes and verified proper evacuation of dispense of the rinse nozzles to the rinse mechanism. A check accuracy test was performed and the results were within specification. The customer is not using the appropriate rack adapters for the tube size in use.
Patient Sequence No: 1, Text Type: D, B5
[96516931]
A review of the quality control (qc) trace data shows irregularities. Qc was low on (b)(6) 2017 and excessively high on (b)(6) 2017. A specific root cause could not be identified. Additional information was requested for investigation but was not provided. Possible root causes may be related to mispipetting due to a contaminated probe or due to missing rack adapters.
Patient Sequence No: 1, Text Type: N, H10
[97110079]
The customer is not having any further issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01063 |
| MDR Report Key | 6581589 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-22 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-05-01 |
| Date Mfgr Received | 2017-05-04 |
| Date Added to Maude | 2017-05-22 |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 8000 C 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFQ |
| Date Received | 2017-05-22 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 8000 C 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-22 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 | 2017-05-22 |