MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS USA STANDARDIZED

Catalog Number 10759350360

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

After the complained samples were repeated, the customer started using a new cfas lot.Calibration with the new lot brought control values back down closer near the expected mean.The investigation could not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter stated on 24-dec-2019, their third party controls were outside of range low for ldhi2 lactate dehydrogenase acc.To ifcc ver.2 on the cobas integra 400 plus.The analyzer was shut down until (b)(6) 2019.Controls were still outside of range low when tested on (b)(6) 2019.The reporter then re-calibrated their current ldh reagent pack and also calibrated a new ldh reagent pack of lot 42914301.Controls run after the calibrations were within range, although they recovered on the high end of the range.The reporter then pulled samples that were initially tested on (b)(6) 2019 and repeated these using both their current ldh reagent pack and the new ldh reagent pack.Three patient samples had discrepant ldh results.The repeat results from these samples were believed to be correct.These samples were initially tested and repeated for ldh when the assay had been calibrated with calibrator for automated systems usa standardized (cfas) lot 31414101.The first patient sample initially resulted with an ldh value of 169 u/l on (b)(6) 2019.The sample was repeated on (b)(6) 2019 using the current reagent pack, resulting with a value of 236 u/l.When repeated using the new reagent pack on (b)(6) 2019, the sample resulted with a value of 251 u/l.The second patient sample, from a (b)(6) year old female born on (b)(6), initially resulted with a value of 174 u/l on (b)(6) 2019.The sample was repeated on (b)(6) 2019 using the current reagent pack, resulting with a value of 302 u/l.When repeated using the new reagent pack on (b)(6) 2019, the sample resulted with a value of 246 u/l.The third patient sample, from a (b)(6) year old male born on (b)(6), initially resulted with a value of 116 u/l on (b)(6) 2019.The sample was repeated on (b)(6) 2019 using the current reagent pack, resulting with a value of 181 u/l.When repeated using the new reagent pack on (b)(6) 2019, the sample resulted with a value of 165 u/l.The serial number of the integra 400 plus analyzer is (b)(4) the ldh reagent lot number used for initial sample testing was 41144401, with an expiration date of 30-jun-2020.

• Brand Name: CALIBRATOR FOR AUTOMATED SYSTEMS USA STANDARDIZED
• Type of Device: CALIBRATOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 9600925
• MDR Text Key: 219779859
• Report Number: 1823260-2020-00156
• Device Sequence Number: 1
• Product Code: JIX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 10759350360
• Device Lot Number: 31414101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR