MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CALCITONIN IMMUNOASSAY; CALCITONIN TEST SYSTEM

Model Number CALCITONIN

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

The country of origin is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received a questionable elecsys calcitonin immunoassay result from the cobas 6000 e 601 module serial number (b)(4).The initial result was 1.64 pg/ml.Using 2 different non-roche instruments, the results were 135 pg/ml and 163 pg/ml the 1.64 pg/ml result was reported outside the laboratory.

Manufacturer Narrative

Review of data did not reveal any malfunction of the product or analyzers or any handling issue during pre-analytics that could explain the difference in results between elecsys calcitonin immunoassay and the clia calcitonin assays.The results of a diagnostic test should always be assessed in conjunction with the patients medial history, clinical examination and other findings.The sample was requested for further investigation however it was no longer available.

• Brand Name: ELECSYS CALCITONIN IMMUNOASSAY
• Type of Device: CALCITONIN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10202307
• MDR Text Key: 200626621
• Report Number: 1823260-2020-01557
• Device Sequence Number: 1
• Product Code: JKR
• Combination Product (y/n): N
• PMA/PMN Number: K132828
• 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: 08/10/2020

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
• Device Operator: Health Professional
• Device Model Number: CALCITONIN
• Device Catalogue Number: 06445853190
• Device Lot Number: 41697900
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/30/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 05/30/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR