MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-24 for LACT GEN.2 03183700190 manufactured by Roche Diagnostics.
[114822894]
This event occurred in (b)(6). Medwatch field facility name - the full facility name was provided as (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[114822895]
The customer stated that they received an erroneous result for one patient sample tested for lact2 lactate gen. 2 (lact) on a cobas integra 400 plus (i400+). The sample initially resulted as 0. 11 mmol/l and this value was reported outside of the laboratory to the ward. The result did not match previous results of the patient, so the ward complained about the result. Controls were measured on the lact assay and they were found to be too low. The customer changed the reagent cassette and repeated the sample. The repeat result of the sample was 1. 78 mmol/l. Controls were repeated on the new cassette and the values were within range, matching previous values. No adverse events were alleged to have occurred with the patient. The i400+ analyzer serial number was (b)(4). 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 | 2018-07-24 |
| Model Number | NA |
| Catalog Number | 03183700190 |
| Lot Number | 30875201 |
| Device Expiration Date | 2019-02-28 |
| 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 |