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 2017-09-12 for ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER E MODULE manufactured by Roche Diagnostics.
[87219083]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[87219084]
The customer received a questionable low elecsys insulin result for one patient sample that was tested in a batch of 150 samples. The initial result was 0. 452? U/ml. On (b)(6) 2017, the sample was repeated on a cobas 6000 e 601 module and the results were 4. 71? U/ml and 4. 66? U/ml. The result of 4. 66? U/ml was reported to the patient. There was no allegation of an adverse event. The reagent lot number was 215871. The expiration date was requested but was not provided. All qc results on the date of testing were within the specifications. The field service representative performed a gripper adjustment due to "tip/cup" error alarms. The investigation could not determine a specific root cause. Based on the data provided, a general reagent or instrument issue could be excluded. The most likely root cause was a pre-analytical issue or bubbles or foam on the reagent surface or on system reagent surface. Other typical causes for this type of event include issues with sample quality or insufficient maintenance of the analyzer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01960 |
| MDR Report Key | 6858435 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-12 |
| Date of Report | 2017-09-12 |
| Date of Event | 2017-08-16 |
| Date Mfgr Received | 2017-08-23 |
| Date Added to Maude | 2017-09-12 |
| 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 | ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CFP |
| Date Received | 2017-09-12 |
| Model Number | E MODULE |
| 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 | ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-12 |
| Model Number | E MODULE |
| 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 | 2017-09-12 |