MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-05-30 for COBAS E 411 IMMUNOASSAY ANALYZER E411 DISK 4775279001 manufactured by Roche Diagnostics.
[76192179]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76192180]
The customer indicated that during correlation testing they observed an erroneous result for 1 patient tested for elecsys acth test system (acth) on the cobas e 411 immunoassay analyzer. The initial acth result from the primary tube at 12:50 p. M. Was 53. 75 pg/ml. This result was reported outside of the laboratory to the physician. The sample from the primary tube was repeated at 1:13 p. M. For the correlation study on a different e411 analyzer and the result was 13. 3 pg/ml. The customer then put the sample in a hitachi cup and repeated the sample twice on both e411 analyzers. The results at 1:32 p. M. On both e411 analyzers were 13. 0 pg/ml. The results at 2:14 p. M. On both e411 analyzers were 13. 0 pg/ml. The repeat results are believed to be correct. Product labeling indicates that samples are viable at 22 degrees celsius for 2 hours. No adverse event occurred. The acth reagent lot was 13189301 with an expiration date of 06/30/2017. The customer did not do anything other than repeat the patient sample. Since the repeat results were correct, the customer has refused a service visit. Complaint data was reviewed and no similar complaints on a like instrument were found in the past 12 months. No other similar complaints were identified for acth lot number 13189300.
Patient Sequence No: 1, Text Type: D, B5
[76529556]
The last preventive maintenance was performed on 03/21/2017. A specific root cause was not identified. Additional information was requested for investigation but was not provided. A general reagent issue can be excluded based on the qc data provided by the customer. The most likely root cause of the issue may be related to pre-analytical handling at the customer site (e. G. Too short clotting time resulting in clot formation during incubation). A more general possibility could be bubbles or foam on the reagent surface or system reagent surface or any general system specific issue (e. G. Dirt on the gripper finger). 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 | 1823260-2017-01108 |
| MDR Report Key | 6598014 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-30 |
| Date of Report | 2017-05-31 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-05-10 |
| Date Added to Maude | 2017-05-30 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | CKG |
| Date Received | 2017-05-30 |
| Model Number | E411 DISK |
| Catalog Number | 4775279001 |
| 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 | 2017-05-30 |
| Model Number | E411 DISK |
| Catalog Number | 4775279001 |
| 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 | 2017-05-30 |