MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IRON GEN.2; PHOTOMETRIC METHOD, IRON (NON-HEME)

Catalog Number 03183696122

Device Problem Non Reproducible Results (4029)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.The event was consistent with a sample handling or maintenance issue.As the issue appeared to be resolved by using a new reagent cassette, a general issue was unlikely.

Event Description

There was an allegation of a questionable low iron gen.2 result from cobas integra 400 plus analyzer serial number (b)(4).The initial result was 1.6 mol/l.The same sample was tested in another laboratory with an abbott instrument and the result was 6.1 mol/l.After the customer replaced the reagent cassette, the same sample was repeated and the result was equal to that obtained on the abbott instrument.No specific data was provided.The questionable result was not reported outside of the laboratory.

• Brand Name: IRON GEN.2
• Type of Device: PHOTOMETRIC METHOD, IRON (NON-HEME)
• 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: 12266276
• MDR Text Key: 268333466
• Report Number: 1823260-2021-02255
• Device Sequence Number: 1
• Product Code: JIY
• UDI-Device Identifier: 04015630918904
• UDI-Public: 04015630918904
• Combination Product (y/n): N
• Reporter Country Code: BK
• PMA/PMN Number: K892838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 03183696122
• Device Lot Number: 538624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• 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