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 2017-04-03 for COBAS E 411 IMMUNOASSAY ANALYZER E411 RACK 04775201001 manufactured by Roche Diagnostics.
[71688023]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[71688024]
The customer received questionable high elecsys brahms pct results for two patient samples. Patient 1: the initial result was 14. 84 ng/ml.. The repeat result was 0. 038 ng/ml.. The repeat result on another cobas e 411 immunoassay analyzer was 0. 020 ng/ml with a data flag. The result from a new sample from the patient was 0. 033 ng/ml. Patient 2: the initial result was 14. 84 ng/ml. The repeat result was 0. 250 ng/ml. Information concerning if any erroneous result was reported outside the laboratory was requested but was unknown. There was no allegation was an adverse event. The reagent lot number was 121669. The expiration date was requested but was not provided. An issue with the database or the software was suspected. Information was provided that the customer had not been performing the "sample data clear" in the software as recommended. Service personnel visited the site and performed the "sample data clear", liquid flow cleaning, calibration, and qc which was successful. Based on the data provided, a reagent issue was excluded.
Patient Sequence No: 1, Text Type: D, B5
[74718926]
The initial result was released to the physician who requested the laboratory repeat testing as the result did not correlate clinically for the patient. Further investigation by the manufacturer confirmed there was a problem with the software. This issue occurs when the sample database is filled with "not documented samples" due to the printer setting selected. This issue is typically avoided by the customer performing "sample data clear" in the software as recommended. However, it was confirmed the customer was not performing this action as recommended which led to the issue.
Patient Sequence No: 1, Text Type: N, H10
[115806297]
In very rare cases a software malfunction in the sample and control data file can occur which may lead to a potential data mismatch. This software malfunction only occurs when the "sample data clear" function is not performed daily as indicated in the operator? S manual, and when the sample and control data file is filled with > 2000 records. The issue described above can lead to result mismatch (wrong test order and wrong result reporting). All tests that are run on the affected analyzers are potentially affected. The manufacturer has confirmed this malfunction of the system. Hitachi will resolve this issue with a new software version. This new software will prevent samples from being ordered and run on the cobas e 411 analyzer when the sample and control data file is full. A workaround has been provided to customers until the updated software version is available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00694 |
| MDR Report Key | 6452915 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-03 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-03-09 |
| Date Mfgr Received | 2017-03-13 |
| Date Added to Maude | 2017-04-03 |
| 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 E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | PMT |
| Date Received | 2017-04-03 |
| Model Number | E411 RACK |
| 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 462500457 US 462500457 |
| Brand Name | COBAS E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-03 |
| Model Number | E411 RACK |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-03 |