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 2017-08-29 for COBAS E 411 IMMUNOASSAY ANALYZER E411 DISK 04775279973 manufactured by Roche Diagnostics.
[86137531]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86137532]
The customer stated that they received a discrepant result for one patient sample tested for elecsys brahms pct (pct) on a cobas e 411 immunoassay analyzer (e411). The sample initially resulted as 0. 094 ng/ml and this value was reported outside of the laboratory. The sample was repeated, resulting as 10. 94 ng/ml. The sample was also repeated a second time, resulting as 11. 65 ng/ml. The 10. 94 ng/ml value was believed to be correct and a corrected report was issued. The patient was under hospitalization and the physician was ready to release the patient due to the low initial result. The patient remained hospitalized. After the result was corrected, the patient received no additional treatment and was later discharged. No adverse events were alleged to have occurred with the patient. The pct reagent lot number was 23285901, with an expiration date of 09/30/2018. The field service engineer determined that there were possible measuring cell issues or bubbles. He checked the analyzer, replaced the measuring cell, and tightened a "probe cap. ". He ran performance testing and this was within acceptable limits. He also performed a blank cell calibration. The customer ran calibrations and quality controls; these were within their acceptable limits. A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. A general reagent issue could be excluded. Calibration signals were slightly below the expected range, but there was no indication of an issue. Quality controls were within range. The centrifugation time of the sample was too short. Possible root causes for this event may be sample quality and insufficient maintenance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01840 |
| MDR Report Key | 6827402 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-29 |
| Date of Event | 2017-08-10 |
| Date Mfgr Received | 2017-08-10 |
| Date Added to Maude | 2017-08-29 |
| 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 | PMT |
| Date Received | 2017-08-29 |
| Model Number | E411 DISK |
| Catalog Number | 04775279973 |
| 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 E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-29 |
| Model Number | E411 DISK |
| Catalog Number | 04775279973 |
| 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 | 2017-08-29 |