MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-06-19 for COBAS E411 RACK SYSTEM 04775201001 manufactured by Roche Diagnostics.
[5808777]
The customer complained of erroneous results for 3 patient samples tested for vitamin b12. The erroneous results for patient 1 were reported outside of the laboratory. It is not known if the erroneous results for patients 2 and 3 were reported outside of the laboratory. Patient sample 1 initial vitamin b12 result was <30 pg/ml. The sample was repeated and the result was 32 pg/ml. This result was reported to the physician who doubted the result and requested the sample be tested in another laboratory. The sample was repeated on an e170 analyzer and the result was 152. 4 pg/ml. Patient sample 2 ((b)(6) male) initial vitamin b12 result was <30 pg/ml. The sample was sent to another laboratory where it was repeated on an e170 analyzer and the result was 217 pg/ml. Patient sample 3 (gender and dob is not known) initial vitamin b12 result was 130 pg/ml. The sample was sent to another laboratory where it was repeated on an e170 analyzer and the result was 325 pg/ml. No adverse event occurred. The vitamin b12 reagent lot was 183415 with an expiration date of 02/29/2016. Calibration and quality controls were within specification. The measuring cell was last changed on (b)(6) 2013. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
[13493465]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[14496503]
Based on the limited data available, a clear root cause could not be identified. A possible root cause may be related to an instrument issue and/or a pre-analytical issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03682 |
| MDR Report Key | 4857149 |
| Report Source | 01,05,06 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-07-07 |
| Date of Event | 2015-05-21 |
| Date Mfgr Received | 2015-06-05 |
| Date Added to Maude | 2015-06-19 |
| 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 | 0 |
| 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 E411 RACK SYSTEM |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CDD |
| Date Received | 2015-06-19 |
| Model Number | NA |
| Catalog Number | 04775201001 |
| 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 46250 US 46250 |
| Brand Name | COBAS E411 RACK SYSTEM |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-06-19 |
| Model Number | NA |
| Catalog Number | 04775201001 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-19 |