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 2017-10-02 for COBAS INTEGRA 400 PLUS I400+ 03245233692 manufactured by Roche Diagnostics.
[89573676]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89573677]
The customer stated that they received an erroneous result for one patient sample tested for ldl_c ldl-cholesterol plus 2nd generation (ldl) on a cobas integra 400 plus (i400+). The customer stated that the issue occurred approximately 2 months ago, so an exact date of event could not be provided. The sample initially resulted as 197 mg/dl and this value was reported outside of the laboratory. The result was questioned by the doctor, so the sample was repeated. The repeat result was 97 mg/dl and this value was believed to be correct. The patient was not adversely affected. The ldl reagent lot number and expiration date were asked for, but not provided. The customer stated that he did not perform any actions to resolve the issue and that there have been no further issues since this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02165 |
| MDR Report Key | 6907336 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-02 |
| Date of Report | 2017-10-12 |
| Date of Event | 2017-07-14 |
| Date Mfgr Received | 2017-09-14 |
| Date Added to Maude | 2017-10-02 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | LBR |
| Date Received | 2017-10-02 |
| Model Number | I400+ |
| Catalog Number | 03245233692 |
| 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 | 2017-10-02 |
| Model Number | I400+ |
| Catalog Number | 03245233692 |
| 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 | 2017-10-02 |