MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-06-21 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[47905708]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[47905709]
The customer complained of erroneous low results for 4 patient samples tested for either insulin or connecting peptide (c-peptide). It is not clear if the results are from 4 different patients or if the results are from different samples from the same patient. It is not known if any erroneous results were reported outside of the laboratory. Patient sample 1 initial insulin result was <0. 2 uu/ml. The repeat result was 82. 6 uu/ml. Patient sample 2 initial insulin result was <0. 2 uu/ml. The repeat result was 5. 1 uu/ml. Patient sample 3 initial c-peptide result was <0. 1 ng/dl. The repeat result was 4. 3 ng/dl. Patient sample 4 initial c-peptide result was <0. 1 ng/dl. The repeat result was 2. 8 ng/dl. No adverse event occurred. The insulin and c-peptide reagent lot numbers and expiration dates were not provided. A system maintenance check was last performed on 05/25/2016. The customer site was visited by the field service engineer (fse) and no instrument issues were identified which would have affected the measurement of the results. Bubbles were identified in the reagent. The customer has had no further issues with erroneous results. A general instrument issue can most likely be excluded based on the data provided. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Based on the information available, the bubbles in the reagent, identified by the fse, are the most likely root cause of the erroneously low results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-00790 |
| MDR Report Key | 5738943 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-06-21 |
| Date of Report | 2016-06-21 |
| Date of Event | 2016-06-09 |
| Date Mfgr Received | 2016-06-09 |
| Date Added to Maude | 2016-06-21 |
| 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 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CFP |
| Date Received | 2016-06-21 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-21 |