MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-21 for LACT GEN.2 03183700190 manufactured by Roche Diagnostics.
[103177792]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103177793]
The customer complained of erroneous low results for 1 neonate ((b)(6)) patient tested for lact2 lactate gen. 2 (lact2) on 2 cobas 8000 c 502 modules. The initial lact2 result from c502 module a was 2. 7 mg/l. The result from c502 module b was 1. 4 mg/l. These results were reported outside of the laboratory where they were questioned by the doctor as they didn't correspond to the patient's clinical condition. The doctor requested repeat testing. The sample was repeated using a 1:10 dilution and the result was 97. 0 mg/l (calculated result 970 mg/l). The sample was also repeated using a 1:100 dilution and the result was 8. 2 mg/l (calculated result 820 mg/l). The patient was not incorrectly treated based on the low results as the doctor immediately questioned the results. No adverse event occurred due to the device. The c502 module a serial number was (b)(4). The c502 module b serial number was not provided. The patient sample was submitted for investigation and run on a cobas 6000 c (501) module. The customer's results could not be confirmed: the undiluted result was 11. 24 mg/l. The calculated result from a 1:10 dilution was 11. 14 mg/l. The calculated result from a 1:50 dilution was 12. 57 mg/l. A general reagent issue was not identified. The investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: D, B5
| Brand Name | LACT GEN.2 |
| Generic Name | LACTIC ACID TEST SYSTEM |
| Product Code | KHP |
| Date Received | 2018-03-21 |
| Model Number | NA |
| Catalog Number | 03183700190 |
| Lot Number | 290621 |
| ID Number | NA |
| Device Expiration Date | 2018-11-30 |
| 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 |