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 2017-07-14 for COBAS INTEGRA 400 PLUS I400+ manufactured by Roche Diagnostics.
[80080141]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[80080142]
The customer received a questionable high etoh2 ethanol gen. 2 result for one patient sample. The initial etoh2 result was 23. 2 mg/dl. The customer performed ggt testing as a confirmatory test and the result was 18 u/l (normal). The sample was repeated for ethanol and the results were 0. 6 mg/dl and 1. 7 mg/dl. No erroneous result was reported outside the laboratory. There was no allegation of an adverse event. The reagent lot number was 22327901 with an expiration date of 9/30/2017. A specific root cause could not be determined. Based on the calibration and qc data provided, a general issue with the reagent or instrument could be excluded. Review of the reaction kinetics provided did not indicate any issue. A possible cause could have been contamination from another sample or from a disinfectant containing ethanol used to clean the probes, system surface, or the laboratory environment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01466 |
| MDR Report Key | 6714660 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-14 |
| Date of Report | 2017-07-14 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-06-28 |
| Date Added to Maude | 2017-07-14 |
| 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 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DIC |
| Date Received | 2017-07-14 |
| Model Number | I400+ |
| 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 INTEGRA 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-07-14 |
| Model Number | I400+ |
| 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 | 2017-07-14 |