MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ACTH TEST SYSTEM; RADIOIMMUNOASSAY, ACTH

Catalog Number 03255751190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The sample was requested for investigation.

Event Description

The initial reporter complained of high results not corresponding to the clinical condition for 1 patient sample tested for elecsys acth test system (acth) on a cobas 6000 core unit.The initial result from the cobas 6000 system was > 2000 ng/l.As this result was not consistent with the patient's clinical condition the customer repeated the sample and then treated the sample with polyethylene glycol (peg) precipitation and all the results were > 2000 ng/l.The customer also diluted the sample 1:2, 1:4 and 1:8 with results of 3310 ng/l, 3894 ng/l and 4574 ng/l respectively.The questionable results were not reported outside of the laboratory.The customer suspects an interference.The core unit serial number was (b)(4).

Manufacturer Narrative

The customer tested the sample on a siemens immulite 2000 instrument and the acth result was > 1250 ng/l (above the respective measuring range).The customer performed dilution testing.Product labeling states that dilution is "not necessary due to the broad measuring range." qc results at the customer site were within the acceptable daily ranges.Maintenance was performed as recommended.Two plasma samples from the patient were received for investigation.The customer's non-diluted result for sample 1 was reproduced (> 2000 pg/ml).The 2nd sample was not tested as non-diluted due to insufficient sample material.The investigation performed a dilution experiment on both samples: sample 1: dilution 1:10: 2766.5 pg/ml dilution 1:20: 2836.5 pg/ml sample 2: dilution 1:10: 2606.5 pg/ml dilution 1:20: 2780.0 pg/ml based on the results received, the acth result is considered to be truly high and not due to an interference.A result > 2000 pg/ml is believed to be correct.The investigation did not identify a product problem.The product meets specifications.

• Brand Name: ELECSYS ACTH TEST SYSTEM
• Type of Device: RADIOIMMUNOASSAY, ACTH
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9952897
• MDR Text Key: 214826533
• Report Number: 1823260-2020-01021
• Device Sequence Number: 1
• Product Code: CKG
• Combination Product (y/n): N
• PMA/PMN Number: K060585
• 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: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 03255751190
• Device Lot Number: 399347
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PREDNISONE - DAILY