MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PTH STAT, PARATHYROID HORMONE - PTH, INTACT STAT (SHORT TURN AROUND TIME); RADIOIMMUNOASSAY, PARATHYROID HORMONE

Catalog Number 04892470190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable results for one patient using the elecsys pth stat immunoassay (pth stat) on the cobas e 411 immunoassay analyzer when compared to the results from a cobas 6000 e 601 module (e601) and cobas 8000 e 602 modules (e602).Currently, the patient has destabilized calcium homeostasis.He has a history of serious unspecified bone and skeletal structure issues, and has undergone a thyroidectomy with removal of the parathyroid glands.On an unspecified date, the initial result from a plasma sample on the e411 was >2000 pg/ml.On an unspecified date, an aliquot of the original plasma sample was pre-treated with 20% polyethylene glycol (peg) and analyzed in another laboratory.The result from an e601 was "around 50 pg/ml".The patient's physician was informed of the discrepant results and did not accept them.The customer could not determine which of the two results corresponded to the patient's clinical picture.The value of >2000 pg/ml corresponded to the patient's skeletal issues, but the value of "around 50 pg/ml" corresponded to the patient's medical history of thyroid/parathyroid removal.The customer alleged that there was hama interference with the assay, leading to the implausibly high result.Due to the discrepant results and alleged interference, the customer proceeded with additional testing in her laboratory and other laboratories.Refer to the attachment for all patient results.Additional clarification was requested regarding the date of event and chronological order of sample analysis.There was no allegation of an adverse event with the patient.The e411 serial number is (b)(4).The e601 serial number was requested but not provided.The e602 serial numbers were requested but not provided.Calibration signals were a little low but within expected range.There was some variability in the qc level 2.Investigation activities are ongoing.

Manufacturer Narrative

The following is a correction to the previously reported information: the customer received questionable results for one patient using the elecsys pth stat immunoassay (pth stat) on the cobas e 411 immunoassay analyzer when compared to the results from cobas 8000 e 602 modules (e602).No results were obtained using an e601.On an unspecified date before or on (b)(6) 2017, the initial result from a plasma sample on the e411 was >2000 pg/ml.On (b)(6) 2017, an aliquot of the original plasma sample was pre-treated with 20% polyethylene glycol (peg) and analyzed in another laboratory ((b)(6)).The result from an e602 was 53 ng/dl with a data flag.The following is additional information: date of event: this was confirmed to be (b)(6) 2017 as previously reported.(b)(4).

Manufacturer Narrative

Further investigation of the sample confirmed the high result provided by the customer, as well as the presence of a human anti-mouse antibody (hama) interferent.This interferent is documented in product labeling.Further clarification of the observed discrepant results is not possible with available methods and the current state of the art.A review of complaints from july 2011 to july 2017 of the pth and pth stat assays showed 8 total complaints out of more than (b)(4) million tests sold.The incidence rate is (b)(4).

• Brand Name: PTH STAT, PARATHYROID HORMONE - PTH, INTACT STAT (SHORT TURN AROUND TIME)
• Type of Device: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6515658
• MDR Text Key: 73516372
• Report Number: 1823260-2017-00869
• Device Sequence Number: 1
• Product Code: CEW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K070709
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04892470190
• Device Lot Number: 185005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR