MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MYOGLOBIN; MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 12178214122

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for the elecsys myoglobin immunoassay (myo) on an unknown roche analyzer.No erroneous results were reported outside of the laboratory.The sample initially resulted as 1300 ng/ml.The sample was diluted manually x11 and then repeated with a x100 automatic dilution, resulting with a final value of 289000 ng/ml.The sample was also diluted manually x21 and then repeated with a x100 automatic dilution, resulting with a final value of 350000 ng/ml.No adverse events were alleged to have occurred with the patient.The model and serial number of the roche analyzer were asked for, but not provided.It was suspected that the sample exhibited a prozone effect since the myo value exceeds 30000 ng/ml.Product labeling indicates that there is no high-dose hook effect at myoglobin concentrations up to 30000 ng/ml.No foam or clots were visible within the sample.

Manufacturer Narrative

Product labeling instructs the customer to dilute samples with myoglobin concentrations above the measuring range.The sample in question did not require a dilution.When dilution is applied, labeling recommends a dilution factor of 1:10, not 1:1100 or even higher.A prozone effect is typically evident with stable results independent of dilution factor.This phenomenon was not seen with the complained patient sample.A prozone effect may be present, but cannot be proven based on the provided information.Investigations determined the issue to not be related to reagent or analyzer issues.

• Brand Name: MYOGLOBIN
• Type of Device: MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7548542
• MDR Text Key: 109902294
• Report Number: 1823260-2018-01618
• Device Sequence Number: 1
• Product Code: DDR
• Combination Product (y/n): N
• PMA/PMN Number: K083260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12178214122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1