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 2017-11-06 for COBAS INTEGRA 400 PLUS I400+ 03245233001 manufactured by Roche Diagnostics.
[92180399]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[92180400]
The customer complained of an erroneous low result for 1 patient sample tested for bilt2 bilirubin total dpd gen. 2 (bilt2) on a cobas integra 400 plus (i400+). It is not known if the erroneous result was reported outside of the laboratory. The initial bilt2 result was 0. 01 mg/dl. Repeat testing was performed on another i400+ analyzer with a bilt2 result of 1. 21 mg/dl. The bilt2 reagent lot and expiration date were requested but not provided. There was no allegation of an adverse event. The customer stated that they have already detected what they believe the problem to be. They believed the sample was at fault because after the initial discrepant result they performed maintenance and measured qc and no other problems were observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02536 |
| MDR Report Key | 7002589 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-06 |
| Date of Report | 2018-03-27 |
| Date of Event | 2017-10-18 |
| Date Mfgr Received | 2017-10-18 |
| Date Added to Maude | 2017-11-06 |
| 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 | MQM |
| Date Received | 2017-11-06 |
| Model Number | I400+ |
| Catalog Number | 03245233001 |
| 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 | 2017-11-06 |
| Model Number | I400+ |
| Catalog Number | 03245233001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-11-06 |