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 2016-11-30 for COBAS 8000 E 602 MODULE E602 05990378001 manufactured by Roche Diagnostics.
[61148285]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[61148286]
The customer received questionable low elecsys ferritin results for one patient sample that had been aliquoted from the primary sample tube at another site. The initial result was 13 ng/ml and was reported outside the laboratory. The doctor called and questioned the result as the patient has a history of ferritin results in the mid-2000 range. The result from a previous sample on (b)(6) 2016 was 2344 ng/ml. Between the time the initial result was generated and when the repeat testing was performed, the customer migrated the ferritin assay to another cobas e602 analyzer because they were balancing their tests across the analyzers. All repeat testing was performed on another cobas e602 analyzer. The customer repeated the sample and the result was 2000 ng/ml with a data flag. After automatic dilution, the result was 2319 ng/ml. The sample from (b)(6) 2016 was then retested and the result was 2000 ng/ml with a data flag. After automatic dilution, the result was 2371 ng/ml. The customer contacted the doctor with the updated result and posted a corrected report. The patient was not adversely affected. The reagent lot number was 13307004 with an expiration date of 6/30/2017. The field service representative found there possibly a sample issue. He flushed the sample and reagent pathways and checked the sample aspiration. He verified the calibration and qc data. Based on the information provided, a specific root cause could not be identified. Additional information for further investigation was requested but was not provided. A general reagent issue could not be detected. General root causes for this type of issue include issues with sample quality or insufficient maintenance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-01869 |
| MDR Report Key | 6134878 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-30 |
| Date of Report | 2016-11-30 |
| Date of Event | 2016-11-15 |
| Date Mfgr Received | 2016-11-16 |
| Date Added to Maude | 2016-11-30 |
| 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 |
| 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 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JMG |
| Date Received | 2016-11-30 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-11-30 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 | 2016-11-30 |