MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IRON2; PHOTOMETRIC METHOD, IRON (NON-HEME)

Catalog Number 03183696122

Device Problems Low Test Results (2458); Calibration Problem (2890)

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

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number was (b)(6).The investigation is ongoing.

Event Description

There was an allegation of qc issues and questionable iron gen.2 results from the cobas integra 400 plus analyzer.One example was an initial result of 7 ug/dl and a repeat result of 53 ug/dl.The questionable results were not reported outside of the laboratory.

Manufacturer Narrative

The customer reported they typically have to calibrate several times before the calibration passes and keep the cfas calibrator material in the refrigerator for 7 days before making a new bottle.The current cfas being used by the customer was reconstituted on (b)(6) 2023.Per product labeling, the stated stability of the cfas calibrator material is only 2 days at 2-8c.The customer installed a new pack of the reagent, reconstituted fresh cfas material, and calibrated the new reagent pack.The customer confirmed the issue was resolved.The investigation determined the issue was due to a use error and was resolved by customer education regarding product handling.

• Brand Name: IRON2
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17776812
• MDR Text Key: 323765162
• Report Number: 1823260-2023-03025
• Device Sequence Number: 1
• Product Code: JIY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 03183696122
• Device Lot Number: 64195701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female