MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-26 for MAGNA PURE COMPACT NUCLEIC ACID ISOLATION KIT I 03730964001 manufactured by Roche Molecular Systems, Inc..
[115189303]
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).
Patient Sequence No: 1, Text Type: N, H10
[115189304]
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.
Patient Sequence No: 1, Text Type: D, B5
[115974004]
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).
Patient Sequence No: 1, Text Type: N, H10
[115977020]
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).
Patient Sequence No: 1, Text Type: N, H10
[137554552]
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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2018-00009 |
| MDR Report Key | 7723792 |
| Date Received | 2018-07-26 |
| Date of Report | 2019-02-15 |
| Date of Event | 2018-05-02 |
| Date Mfgr Received | 2018-07-10 |
| Date Added to Maude | 2018-07-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAGNA PURE COMPACT NUCLEIC ACID ISOLATION KIT I |
| Generic Name | NA |
| Product Code | PPM |
| Date Received | 2018-07-26 |
| Model Number | NA |
| Catalog Number | 03730964001 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-07-26 |