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 2017-03-10 for COBAS E 411 IMMUNOASSAY ANALYZER E411 RACK manufactured by Roche Diagnostics.
[69759981]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69759982]
The customer stated that they received an erroneous result for one patient sample tested for the elecsys vitamin b12 immunoassay (b12) on a cobas e 411 immunoassay analyzer (e411). The sample initially resulted as < 60. 00 pg/ml accompanied by a data flag and this value was reported outside of the laboratory to the doctor. The sample was repeated and the result was 280. 6 pg/ml. The patient was not adversely affected. The b12 reagent lot number was 17748601. The reagent expiration date was asked for, but not provided. The field service engineer performed maintenance and cleanings on the analyzer. He detected many handling failures at the customer site. The customer was having calibration and control issues often. The engineer explained proper handling to the customer. He ran calibration and controls. The field service engineer later performed additional actions at the customer site. He changed, cleaned, and adjusted many parts. After these actions, the b12 reagent was calibrated 3 times and signals were within expected ranges. Controls met specifications. No further issues were noted by the customer after these actions. A specific root cause could not be determined based on the provided information. It was noted that 4 calibrations were carried out on the date of the event and signals were fluctuating. Control data also showed that results were fluctuating, with a lot of results outside of range. The used control kit was found to be expired in (b)(6) 2017. Possible root causes for this event may be sample quality, bubbles foam on the sample or reagent surfaces, sample tubes not being placed on the rack straight, sample tube size not within specifications, low sample volume, insufficient electromagnetic interference compliance in the laboratory, dirt on the gripper finger or sample probe, and insufficient maintenance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00528 |
| MDR Report Key | 6396459 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-10 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-02-23 |
| Date Mfgr Received | 2017-02-23 |
| Date Added to Maude | 2017-03-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CDD |
| Date Received | 2017-03-10 |
| Model Number | E411 RACK |
| Catalog Number | ASKU |
| 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 | 2017-03-10 |
| Model Number | E411 RACK |
| Catalog Number | ASKU |
| 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 | 2017-03-10 |