MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS IGF-1; RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

Catalog Number	07475918190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The samples had been initially tested immediately after thawing.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable low igf-1 elecsys results from cobas e 801 analytical unit serial number (b)(4) that did not match the clinical picture of the patients.One example was provided of an initial result of 80.2 ng/ml and a repeat result of 149 ng/ml.The questionable results were reported outside of the laboratory and were questioned by the physician.The repeat results fit the patients' histories and were considered valid.
Additional 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 preanalytical issue as the problem appeared to be solved when the samples were not frozen but just cooled.The calibration and qc data do not point to a reagent or instrument problem.

• Brand Name: ELECSYS IGF-1
• Common Device Name: RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE
• 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: 15544191
• Report Number: 1823260-2022-03059
• Device Sequence Number: 6511268
• Product Code: CFL
• UDI-Device Identifier: 07613336140864
• UDI-Public: 07613336140864
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 07475918190
• Device Lot Number: 63723401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown