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

Catalog Number	07475896190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys igf-1 result from the cobas e 801 analytical unit.The initial result was > 1600 ng/ml.The following are the results after dilution: a dilution of 1:10 with a result of 1157 ng/ml.A dilution of 1:5 with a result of 1198 ng/ml.A dilution of 1:2 with a result of 1143 ng/ml.A manual dilution of 1:10 with a result of 1153 ng/ml.A manual dilution of 1:5 with a result of 1170 ng/ml there was a precipitation result of 1243 ng/ml.They compared the results to a simens analyzer with a result of 640 ng/ml.
Additional Manufacturer Narrative
Through investigation, a standardization issue in the igf-1 assay was identified.In this specific situation, it has been observed that ig-f measurements for patients presenting igf-1 concentrations in the high measuring range (igf-1 > 800 ng/ml) might lead to increased igf-1 results: the plus bias starts at around igf-1 800 ng/ml and increases progressively up to circa 25% at igf-1 1600 ng/ml.According to good clinical practice, the medical decision attributable to potential igf-1 incorrect test results depends significantly on the constellation of diagnostic and clinical parameters such as the degree of analytical variation of affected results, specific affected range, detectability by technical indices, detectability due to clinical implausibility, additional diagnostic testing results and congruence of the overall clinical picture.Thus, both the igf-1 values (obtained increased igf-1 and true igf-1) are clearly above the upper end of the normal range for igf-1 expected values.Together, in the potential clinical scenarios, it is unlikely that clinical care could be significantly influenced by the observed issue.

• Brand Name: ELECSYS IGF-1
• Common Device Name: HUMAN GROWTH HORMONE ASSAY
• 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: 21663127
• Report Number: 1823260-2025-00823
• Device Sequence Number: 18048500
• Product Code: CFL
• UDI-Device Identifier: 07613336143131
• UDI-Public: 07613336143131
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/03/2025

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: 07/31/2025
• Device Catalogue Number: 07475896190
• Device Lot Number: 81739901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENSCI'S POLYETHYLENE GLYCOL
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian