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 2017-08-24 for COBAS 6000 E 601 MODULE E601 manufactured by Roche Diagnostics.
[83750057]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83750058]
The customer complained of erroneous results for 1 patient sample tested for elecsys cea assay (cea) on a cobas 6000 e 601 module. The initial cea result was 0. 637 ng/ml. This result was reported outside of the laboratory where it was questioned. On (b)(6)2017 the sample was repeated and the result was 96. 83 ng/ml. This result was believed to be correct. There was no allegation that an adverse event occurred. The cea reagent lot number was 153910 with an expiration date of 09/30/2017. The pinch tube was last replaced on (b)(6)2017. Liquid flow cleaning was last performed on (b)(6)2017. The customer? S calibration signals are slightly lower than expected. The customer? S quality control results were within the acceptable ranges. An "abnormal sample aspiration" alarm was observed on the alarm trace at the time of the initial cea result. A specific root cause was not identified. Additional information was requested for investigation but was not provided. The most likely root cause of the event was due to a pre-analytical issue due to the "abnormal sample aspiration" alarm at the time of the event. A general product problem has been excluded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01817 |
| MDR Report Key | 6818043 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-24 |
| Date of Event | 2017-08-05 |
| Date Mfgr Received | 2017-08-07 |
| Date Added to Maude | 2017-08-24 |
| 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 | DHX |
| Date Received | 2017-08-24 |
| Model Number | E601 |
| Catalog Number | ASKU |
| 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 |
| Brand Name | COBAS 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-24 |
| Model Number | E601 |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-08-24 |