MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GLUC3 GLUCOSE HK GEN.3; HEXOKINASE, GLUCOSE

Model Number C702

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2021

Event Type  malfunction  

Manufacturer Narrative

Unique device identifier (udi) (b)(4).The field service engineer performed system checks.He removed the current glucose reagent pack and performed precision testing with the standby glucose reagent pack and had acceptable results.The glucose assay was recalibrated and qc passed.He performed precision testing with multiple assays with acceptable results.The investigation is ongoing.

Event Description

The initial reporter received questionable gluc3 glucose hk gen.3 results for 250 patients tested on a cobas 8000 c 702 module.The customer confirmed qc prior to patient testing was acceptable.The initial glucose results were reported outside the laboratory.The customer performed repeat testing with the samples.The customer provided two patient examples of questionable glucose results: at 04:46, patient 1's initial glucose result was 67 mg/dl.At 09:11, the patient's repeat result was 89 mg/dl on a different cobas 8000 c 702 module.At 04:46, patient 2's initial glucose result was 58 mg/dl.At 09:11, the patient's repeat result was 81 mg/dl on a different cobas 8000 c 702 module.The customer determined the repeat results were correct and corrected reports were provided.The glucose reagent lot number was 493600 with an expiration date requested but not provided.

Manufacturer Narrative

D4 unique device identifier (udi) (b)(4).The calibration results were higher than previous calibrations, but the calibration recovery was successful.Qc recovery was out of range on (b)(6) 2021 at 03:49 pm on both levels of qc.The customer provided that their qc was in range for both current and standby reagent packs before normal operation was continued.However, the investigation discovered that there were subsequent qc runs and the qc results were both in range and out of range.Based on the provided data, the investigation was unable to determine if the qc was acceptable before the customer continued with operation.The customer's sample pre-analytical details were requested but not provided.The alarm trace contains one sample short error on the day of the issue.This is an indicator of possible poor sample quality.The investigation determined that the service actions by the field service engineer resolved the issue.

• Brand Name: GLUC3 GLUCOSE HK GEN.3
• Type of Device: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11862199
• MDR Text Key: 252349197
• Report Number: 1823260-2021-01517
• Device Sequence Number: 1
• Product Code: CFR
• Combination Product (y/n): N
• PMA/PMN Number: K061048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: C702
• Device Catalogue Number: 05168791190
• Device Lot Number: 49360000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1