MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 19-9 IMMUNOASSAY; TEST, CARBOHYDRATE ANTIGEN (CA19-9)

Catalog Number 11776193122

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received questionable results for a total of 245 patient samples tested on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170).Of the 245 patient samples, 89 had erroneous test results.The erroneous results were reported outside of the laboratory to the doctor.The affected assays include: the elecsys afp assay (afp), the elecsys ca 19-9 immunoassay (ca 19-9), the elecsys cea assay (cea), the elecsys total psa immunoassay (psa), elecsys ft3 iii (free-t3), the elecsys ft4 ii assay (free-t4), and the elecsys tsh assay (tsh).Patient identifiers for information related to each affected assay: (b)(6).Please refer to the attachment for all patient data.The samples were initially tested on the customer's e170 analyzer (named elecsys on attachment).The elecsys values highlighted in orange are erroneous.The samples were repeated using the abbott architect and wako accuraseed methods.Sample 31 was provided for investigation where it was tested for tsh, free-t3, and free-t4 on a cobas 8000 e 801 module - e801 (see bottom of attachment).No adverse events were alleged to have occurred with the patients.The serial number of the customer's e170 analyzer is (b)(4).The serial number of the e801 analyzer used for investigation was (b)(4).

Manufacturer Narrative

The investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS CA 19-9 IMMUNOASSAY
• Type of Device: TEST, CARBOHYDRATE ANTIGEN (CA19-9)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7638737
• MDR Text Key: 112848578
• Report Number: 1823260-2018-02044
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• PMA/PMN Number: K050231
• 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: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11776193122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR