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 2017-06-09 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[77537133]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77537134]
The customer complained of erroneous results for 1 patient tested for vitamin b12 ii on a cobas 6000 e 601 module. The initial vitamin b12 ii result from the e601 module was <50 pg/ml with a data flag. The sample was repeated on the e601 module and the result was 2000 pg/ml with a data flag. The sample was repeated again on the e601 module and the result was <50 pg/ml with a data flag. This result was reported outside of the laboratory where it was questioned by the physician. The patient was tested by a different laboratory on (b)(6) 2017 using the chemiluminescence method and the vitamin b12 result using a manual dilution of 1:2 was 6463 pg/ml. The patient was tested at a different laboratory on (b)(6) 2017 and the result was >2000 pg/ml. A new sample was obtained from the patient on (b)(6) 2017 and the result from the e601 module was 2000 pg/ml with a data flag. The sample was repeated on the e601 module with a 1:2 dilution and the result was 2000 pg/ml with a data flag. There was no allegation that an adverse event occurred. The vitamin b12 ii reagent lot number was 177486-01. The expiration date was not provided. It is not clear when the last valid calibration was performed. The calibration data provided was from (b)(6) 2017. Quality control data was provided, but it is not clear when the results were generated. A specific root cause could not be identified. Additional information was requested for investigation but was not provided. The low results of <50 pg/ml may be related to issues with sample quality and insufficient maintenance. The high results of >2000 pg/ml may indicate the presence of immunoglobulin-vitamin b12 complex which can cause high results, however this cannot be confirmed as the sample is not available for investigation.
Patient Sequence No: 1, Text Type: D, B5
[118807756]
Analyzer performance testing was within specification. The results from the performance test do not suggest an issue related to the analyzer that would have caused the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01209 |
| MDR Report Key | 6631832 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-09 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-05-18 |
| Date Mfgr Received | 2017-05-25 |
| Date Added to Maude | 2017-06-09 |
| 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 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CDD |
| Date Received | 2017-06-09 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| 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 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-09 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| 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 | 2017-06-09 |