MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. MAGNA PURE COMPACT NUCLEIC ACID ISOLATION KIT I

Catalog Number 03730964001

Device Problem False Negative Result (1225)

Patient Problem Death (1802)

Event Date 05/02/2018

Event Type  Death  

Manufacturer Narrative

A customer site in (b)(6) reported the generation of (b)(6) results from a cerebral spinal fluid (csf) sample processed using the magna pure compact nucleic acid isolation kit i.The processed sample was subject to pcr amplification, using in-house developed primers (these are not specific for (b)(6)), and subsequent gel electrophoresis using the qiagen qiaexcel dna screening kit.The (b)(6) result did not meet the patient's clinical manifestations or subsequent testing performed with other methods, which generated (b)(6) results.The patient had suspected meningitis / encephalitis, and was receiving acyclovir treatment, which was suspended around the time the (b)(6) result was obtained (date of treatment suspension unknown).The patient died, and the cause and date of death was not provided although requested.The magna pure compact nucleic acid isolation kit is a general laboratory use reagent for which the customer was utilizing as part of an in-house in vitro diagnostic (ivd) test.Per the instructions for use, the kit is used for the isolation of genomic dna from mammalian whole blood or cultured cells, total nucleic acids from mammalian serum or plasma, or bacterial dna, from different types of sample of mammalian origin or bacterial cultures, using the magna pure compact instrument.The customer was using the kit in an off-label manner as they were isolating viral nucleic acids (i.E., (b)(6)) from cerebrospinal fluid (csf).During the course of the investigation, it was reported that the customer site did not include an internal control (ic) in the sample during the sample processing on the magna pure compact.Within the instructions for use, it is noted that the magna pure compact instrument offers the option to add an internal control (ic) to the samples during the purification procedure, with the note that "including an internal control is important to detect a possible impairment of the nucleic acid isolation process." additionally, the customer site did not record or track the kit lot of the magna pure compact nucleic acid isolation kit i used during sample processing nor the serial number of the magna pure compact instrument used during the processing procedure.Roche determined that three (3) magna pure compact nucleic acid isolation kit i lots (31161600, 31465400, 31469500) were shipped to this specific customer site through a review of distribution records.A review of the qc kit release data for the aforementioned kit lots shipped to the site was performed and no issues were identified.Additionally, review of complaint history did not show any other escalated cases against the 3 kit lots, to date.As such, no product issue could be found.The customer site is performing their own investigation into the situation.If additional details, including the outcome of their investigation, are provided at a later date, a supplemental report will be submitted.(b)(4).

Event Description

A customer site in (b)(6) reported the generation of (b)(6) results from a cerebral spinal fluid (csf) sample processed using the magna pure compact nucleic acid isolation kit i.The processed sample was subject to pcr amplification, using in-house developed primers (these are not specific for (b)(6)), and subsequent gel electrophoresis using the qiagen qiaexcel dna screening kit.The (b)(6) result did not meet the patient's clinical manifestations, and subsequent testing performed with other methods that generated (b)(6) results.The patient had suspected meningitis / encephalitis, and was receiving acyclovir treatment, which was suspended around the time of the (b)(6) result was obtained (date of treatment suspension unknown).The patient died, and the date of death was not provided.

Manufacturer Narrative

After submission of the initial mdr report (2243471-2017-00009), additional information, including date of death, treatment information, and supplemental testing results, was provided by the customer and included within this report.(b)(4).

Manufacturer Narrative

After the submission of supplemental mdr 2243471-2018-00009 (submitted 03-aug-2018), we identified the information captured "date of death" was not transmitted to fda.As such, the date of death will be captured: (b)(6) 2018.(b)(4).

Manufacturer Narrative

The customer site has completed their internal investigation into this matter.They have indicated that an "expert on the team identified that the amount of (b)(6) present in the sample was low and was not detected by the methodology used, although it was detected in other assays.The laboratory was last accredited by nata (national association of testing authorities) in dec 2017 and has a qa program for (b)(6) nucleic acid testing.A review of the test protocol and sensitivity of the assay has demonstrated 100% concordance for the past 4 years and a limit of detection of 100 copies of virus/ml of sample.It has been determined that the assay is fit for purpose and while commercially available might have the capability to detect of lower concentration of viral particles, they are also known to return false negatives." the site also indicated there should be close liaison between the clinicians and pathologists when there is uncertainty about the results of testing, and following consultation, samples may be referred to another laboratory for repeat testing to provide assurance about the quality of the result.This has been identified as contributing factor and a recommendation has been made to address this at the customer site.(b)(4).

• Brand Name: MAGNA PURE COMPACT NUCLEIC ACID ISOLATION KIT I
• Type of Device: NA
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC.; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 7723792
• MDR Text Key: 115189303
• Report Number: 2243471-2018-00009
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03730964001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2018
• 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 Outcome(s): Death
• Patient Age: 12 YR
• Patient Weight: 107