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 2017-04-18 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[73032109]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[73032113]
The customer obtained high test results for one patient sample using the elecsys acth test system (acth) on the cobas 6000 e 601 module (e601). All results are in units of pg/ml. At 9:24 am, the initial result was 46. 23. At 10:20 am, the sample was repeated with a result of 1. 70. At 11:04 am, the sample was repeated with a result of 1. 90. It was unknown whether the results were released outside of the laboratory. There was no allegation of an adverse event with the patient. The acth lot number and expiration date were requested but not provided. Investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5
[74921059]
A specific root cause for this event could not be identified. Additional information was requested for investigation but was not provided. A general reagent issue could most likely be excluded. The most likely root cause could be a pre-analytical issue (e. G. , not enough clotting time resulting in clot or fibrin formation during incubation). Another potential root cause could be bubbles or foam on the reagent surface or on the system reagent surface. Additional possible root causes for this event may be insufficient electromagnetic interference lab compliance, sample quality, insufficient maintenance, or contamination of the environment with the analyte.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00803 |
| MDR Report Key | 6499945 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-18 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-04-18 |
| 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 | CKG |
| Date Received | 2017-04-18 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-04-18 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-04-18 |