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 2017-06-30 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[78980755]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[78980756]
The customer complained of erroneous results for 3 patients tested for igg-2 tina-quant igg gen. 2 (igg-2) on a cobas 6000 c (501) module. Based on the data provided, erroneous igm-2 tina-quant igm gen. 2 (igm-2) results were also identified for 1 of these patients. The samples are sent to the c501 module from the modular pre-analytic (mpa) system. The mpa makes 2 aliquots and one is tested on the customer's c501 module and the other is sent to the customer's sister site. The sister site performs electrophoresis on the samples and repeats the patient samples on their c8000 system. The customer runs the sample from a cup on the c501 module and the sister site runs the sample from a tube. The samples have been sent back from the sister site in the tubes and repeated on the customer's c501 module and the repeat tests give the correct result. Patient 1 initial igg-2 result on the c501 module was 6. 48 g/l. This result was reported outside of the laboratory. The repeat from the c8000 system used at the sister site was 15. 5 g/l. On (b)(6) 2017 the sample was repeated on the c501 module and the result was 16. 53 g/l. The result was later amended and reported outside of the laboratory as 15. 5 g/l. The last preventive maintenance was the week of (b)(6) 2017. There was a slight fluid leak identified at the time that was slightly diluting chemistries. Service at that time did not resolve the issue. On (b)(6) 2017 patient 2 initial igg-2 result on the c501 module was 44. 23 g/l and the initial igm-2 result was 0. 23 with a data flag. On (b)(6) 2017 the sample was tested on a different c501 module and the igg-2 result was 17. 39 g/l and the igm-2 result was 0. 30 g/l. The sample was repeated on the c501 module in question and the igg-2 result was 16. 33 g/l. It is not known if the erroneous results were reported outside of the laboratory. This information has been requested. On (b)(6) 2017 patient 3 (female with date of birth of (b)(6) 1944) initial igg-2 result on the c501 module was 3. 34 g/l. This result was reported outside of the laboratory. The repeat from the c8000 system used at the sister site was 8. 5 g/l. On (b)(6) 2017 the sample was repeated on the c501 module and the result was 7. 78 g/l. The sample was also repeated on a different c501 module at the customer site and the result was 8. 05 g/l. The result was later amended and reported outside of the laboratory as 8. 5 g/l. The samples looked ok upon visual inspection. The results that were reported were corrected in a timely fashion. No reagent lot numbers or expiration dates were provided. After the initial point of contact, the customer complained about a 4th patient sample with erroneous crpl3 c-reactive protein gen. 3 (crpl3), crea2 and ureal urea/bun results on the c501 module. On (b)(6) 2017 the initial crpl3 result was 1. 81 (unit of measure not provided), the initial crea2 result was 5. 8 (unit of measure not provided), and the initial ureal result was 1. 0 (unit of measure not provided). On (b)(6) 2017 the sample was repeated on the c501 module and the crpl3 result was 66. 40, the crea2 result was 206. 8 and the ureal result was 26. 3. It is not known if the erroneous results were reported outside of the laboratory. This information has been requested. The field service engineer (fse) visited the customer site and checked the rinse levels of the instrument which were all ok. The gear pump pressure was slightly low and this was adjusted. Both sample and reagent lines were decontaminated. Several other parts of the instrument were checked and were found to be within specification. A precision check was run on the igg-2 assay and the results were ok. Quality controls (qc) were run on the c 501 module and were ok.
Patient Sequence No: 1, Text Type: D, B5
[118808450]
The customer clarified that the erroneous results for patients 2 and 4 were reported outside of the laboratory, however, the corrected results were provided once repeat testing was completed. No patients were adversely affected since no action was taken based on the erroneous results. The customer states the instrument is performing much better. They have been running samples in duplicate for 1 week and have had no more discrepant results.
Patient Sequence No: 1, Text Type: N, H10
[120549427]
The fse returned to the customer site on 06/26/2017 due to a different issue. The photometer lens holder was removed and the seal had become very brittle and hard. The seal was replaced. Alignment was checked and performance testing was successful. A photometer check was also acceptable. The customer mentioned a concern with the rinse unit mechanism. The fse checked this and all was ok. The customer ran calibration and qc and the results were acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01379 |
| MDR Report Key | 6680638 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-30 |
| Date of Report | 2017-08-23 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2017-06-09 |
| Date Added to Maude | 2017-06-30 |
| 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 |
| 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 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFQ |
| Date Received | 2017-06-30 |
| Model Number | C501 |
| 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 | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-30 |
| Model Number | C501 |
| 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 | 2017-06-30 |