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 2018-04-25 for COBAS INFINITY CORE SOFTWARE 07154003001 manufactured by Roche Diagnostics.
[107088134]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4). Medwatch field phone number was provided as (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[107088135]
The customer stated that they received erroneous values for five patient samples tested for crep2 creatinine plus ver. 2 (crea) on two cobas 8000 c (701) module - c701 analyzers. The values present in the cobas infinity core middleware system did not match the same values generated by the analyzers for the samples. No erroneous values were reported outside of the laboratory as the crea values in the infinity system were not consistent with values of other renal tests. Refer to the attachment for all patient data. Testing orders were assigned to a c701 analyzer (c701 - line 1), but due to a reagent shortage, no values were generated and reagent shortage messages were transmitted to the infinity system. The infinity then generated values higher than 200 umol/l for these same samples (infinity - line 1 result). The customer saw that the values in the infinity system were too high, so the customer checked the results in the software of the c701 - line 1 system. The customer did not find result values for these samples and the software indicated that there was a reagent shortage. Crea testing for the samples was then manually programmed to be repeated on a second c701 analyzer (c701 - line 2) and the samples resulted with values. Results generated with both c701 analyzers were merged into the customer's laboratory information system (lis). The c701 - line 2 repeat results were the values seen in the lis system. The results from the lis did not match with the infinity results. No adverse events were alleged to have occurred with the patients. The crea reagent lot number and expiration date were asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01272 |
| MDR Report Key | 7457409 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-25 |
| Date of Report | 2018-09-20 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-04-02 |
| Date Added to Maude | 2018-04-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INFINITY CORE SOFTWARE |
| Generic Name | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE |
| Product Code | CGX |
| Date Received | 2018-04-25 |
| Model Number | NA |
| Catalog Number | 07154003001 |
| 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 INFINITY CORE SOFTWARE |
| Generic Name | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE |
| Product Code | JQP |
| Date Received | 2018-04-25 |
| Model Number | NA |
| Catalog Number | 07154003001 |
| 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 | 2018-04-25 |