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 2017-08-22 for COBAS INTEGRA 400 PLUS I400+ manufactured by Roche Diagnostics.
[83201292]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[83201293]
The customer received questionable low albt2 tina-quant albumin gen. 2 results for two patient urine samples. Patient 1 had a test for albumin. There was also an albumin/creatinine ratio ordered for this patient. The sample was split, and another albumin test was performed for the albumin/creatinine ratio. The first result was 18. 25 mg/dl and the second result with a 1:20 dilution was 371. 40 mg/dl. These results were reported outside the laboratory. The patient complained about the difference in the results and the laboratory repeated testing on (b)(6) 2017. The first repeat result with a 1:20 dilution was 401. 90 mg/dl and the second result with a 1:20 dilution was 383. 26 mg/dl. Patient 2 initial result on (b)(6) 2017 with a 1:20 dilution was 250. 40 mg/dl. The repeat result was 466. 85 mg/dl with a data flag. The erroneous result was not reported outside the laboratory for this patient. There was no allegation of an adverse event. The reagent lot number was 18315001 with an expiration date of 06/30/2018. Review of the provided calibration and qc data found there were acceptable. The provided reaction kinetic data for patient 1 indicated a high amount of the analyte in the sample and a possible pipetting issue. The field service representative performed precision testing on the analyzer and it was not acceptable. He found an issue with one of the sample probes and with the absorbance photometer. He replaced and adjusted many parts of the analyzer and ran performance testing which was acceptable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01781 |
| MDR Report Key | 6809510 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-22 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2017-08-22 |
| 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 | CJW |
| Date Received | 2017-08-22 |
| Model Number | I400+ |
| Catalog Number | ASKU |
| 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 | 2017-08-22 |
| Model Number | I400+ |
| Catalog Number | ASKU |
| 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 | 2017-08-22 |