MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN B12 II; RADIOASSAY, VITAMIN B12

Model Number B12 G2

Device Problems Crack (1135); Unsealed Device Packaging (1444); Low Test Results (2458); Low Readings (2460)

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

Event Date 08/08/2022

Event Type  malfunction  

Manufacturer Narrative

The customer replaced the reagent kit and the patient and qc results were normal.The customer checked the reagent kit in question, and "a lot" of crystals were at the mouth of the bottle of the pre-treatment solution.There was not a lot of liquid in the bottle suggesting a leak.The reagent kit was requested for investigation.

Event Description

The initial reporter questioned results for qc and multiple patient samples tested with one particular reagent kit of elecsys vitamin b12 ii (vitamin b12 ii) on a cobas 8000 core unit.The customer provided 2 sets of discrepant results.The first set: the initial result was 160.9 pmol/l.The repeat result was > 1476 pmol/l.The 2nd set: the initial result was 36.9 pmol/l.The repeat result was 161.1 pmol/l.The questionable results were reported outside of the laboratory.The 8000 core unit serial number was (b)(4).

Manufacturer Narrative

The reagent kit was received for investigation.Sections d9 and h3 were updated.The reagent packaging was visually inspected and there were water stains on the box.The reagent kit was visually inspected and there were no traces of leakage or damage.The reagent kit was disassembled and there was no damage or visible cracks on the reagent bottles or pre-treatment solution bottle 1.The mouth of pre-treatment solution bottle 2 was damaged.The pre-treatment solution bottle 2 was empty.The investigation is ongoing.

Manufacturer Narrative

No calibration data was provided for the affected reagent kit.Calibration signals from a different reagent kit with the same lot number were acceptable.On 06-aug-2022 qc was low, and out of range for the affected reagent kit.Around the same time, there were other low qc results.The rest of the qc results were within the acceptable range.The reagent kit was received for investigation where calibration could not be generated.An alarm was received: "reagent probe did not detect liquid level of pretreatment." based on a review of worldwide data of qc recovery for the reagent lot used by the customer, no reagent issue was found.The investigation determined the crack in the neck of pre-treatment solution bottle 2 caused the liquid leakage.A general product problem has been excluded.Only single reagent kits are affected.Other reagent kits from the same lot performed within specification at this customer site and other customer sites.The specific causal link between the bottle damage and the issue with the single reagent kit could not be determined.

• Brand Name: ELECSYS VITAMIN B12 II
• Type of Device: RADIOASSAY, VITAMIN B12
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15328777
• MDR Text Key: 305414108
• Report Number: 1823260-2022-02655
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: B12 G2
• Device Catalogue Number: 07212771190
• Device Lot Number: 58858304
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 09/26/2022; 12/06/2022
• Supplement Dates FDA Received: 10/19/2022; 12/13/2022
• 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
• Patient Sequence Number: 1