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 2017-06-01 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[76518058]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[76518059]
The customer received questionable low elecsys cea assay results for multiple patient samples. Data for evaluation was only provided for one of the patient samples. The initial result was 0. 2 ng/ml and the repeat result was 6. 7 ng/ml. Information regarding if any erroneous result was reported outside the laboratory was requested, but it was unknown. There was no allegation of an adverse event. The reagent lot number and expiration date were requested but were not provided. No fibrin was observed in the specimen. The customer received error messages indicating the reagent probe detected noise, bubbles, or a membrane on the reagent surface. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Based on the alarm received by the customer, most likely bubbles on the reagent surface were the root cause for the issue. A general product problem was excluded.
Patient Sequence No: 1, Text Type: D, B5
[79048656]
Results were provided for three additional patient samples with low elecsys cea assay results from the event on (b)(6) 2017. Patient 2 initial result was 0. 2 ng/ml and the repeat result was 2. 48 ng/ml. Patient 3 initial result was 0. 2 ng/ml and the repeat result was 2. 15 ng/ml. Patient 4 initial result was 0. 2 ng/ml and the repeat result was 1. 86 ng/ml. The field service representative performed an instrument check and no issues were found. The system was operating normally since the service visit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01121 |
| MDR Report Key | 6604444 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-01 |
| Date of Report | 2017-06-09 |
| Date of Event | 2017-05-16 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-06-01 |
| 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 | 2017-06-01 |
| 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 | 2017-06-01 |
| 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 | 2017-06-01 |